natgillin/translations-raw huggingface dataset:
б) да провери дали продуктът е разрешен във въпросната държава-членка съгласно процедурите за разрешение, предвидени в Директива 91/414/ЕИО или в този регламент.
(b) to check that the product is authorised in that Member State in accordance with the authorisation procedure laid down in Directive 91/414/EEC or in this Regulation.
Продукти, подлежащи на паралелен внос, не се преопаковат.
Products subject to parallel imports may not be repackaged.
Срокът на валидност на удостоверението за идентичност изтича заедно с разрешението на отправния продукт или при изтичане на разрешението на вносния продукт в държавата-членка, от която се внася.
The identity certificate shall expire with the authorisation of the reference product or the expiry of the authorisation of the imported product in the Member State from which it is exported.
Ако разрешението за отправния продукт не е отменено от съображения за закрила на здравето или околната среда, вносителят има право да продължи да продава внесения продукт в рамките на една година от датата на отмяна на разрешението.
If the authorisation of the reference product is withdrawn for reasons other than health or environmental reasons, the importer may continue to sell the imported product for one year after the date of withdrawal.
Срокът се удължава на 15 години за продукти за растителна защита, за които се отнасят разпоредбите на член 46 и 12 години за продуктите, за които се отнасят разпоредбите на член 46а.
That period shall be extended to 15 years for plant protection products covered by Article 46 and 12 years for those covered by Article 46a .
To encourage research for more sustainable substances and products, it is important for data protection, and thus for the return on the investment, to expand the use of products with a low or lower risk profile.
To encourage research for less harmful substances and products, it is important for data protection, and thus for the return on the investment, to expand the use of products with a low or lower risk profile.
Не се ползва със защита проучване , което е било необходимо само за подновяване или преразглеждане на разрешение.
A study shall not be protected if it was only necessary for the renewal or review of an authorisation.
Не се ползва със защита проучване, което е представено с оглед на преразглеждането или подновяването на разрешение, освен ако такова проучване не е необходимо по силата на изисквания, които произтичат от промяна на правните разпоредби .
A study submitted for the renewal or review of an authorisation shall not be protected except where required for the purposes of amending the legislation .
Член 56, параграф 1 а (нов)
Article 56, paragraph 1 a (new)
Член 56, параграф 2, буква б a) (нова)
Article 56, paragraph 2, point (b a) (new)
ба) в случай на възникване на монополна ситуация.
(ba) where a monopoly is created.
Ако държава-членка счита, че може да възникне монополна ситуация, а потенциалният заявител и притежателят или притежателите на разрешения за продукти за растителна защита, които съдържат едно и също активно , растителнозащитно или синергизиращо вещество, не могат да постигнат споразумение за съвместно извършване на тестове и проучвания върху гръбначни животни, потенциалният заявител уведомява за това компетентния орган на държавата-членка.
Where the Member State considers that a monopoly might be created, and the prospective applicant and the holder or holders of the authorisations for plant protection products containing the same active substance, safener, or synergist cannot reach agreement on the sharing of any tests and studies involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State to that effect.
С оглед гарантиране на справедливо, прозрачно и недискриминационно определяне на разходите по обмена на информация, Комисията може, в съответствие с процедурата по член 76, параграф 3, да приеме насоки за разпределяне на разходите въз основа на тези принципи.
In an endeavour to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way, the Commission may, in accordance with the procedure referred to in Article 76(3), adopt cost-sharing guidelines based on those principles.
Член 59, параграф 3 а (нов)
Article 59, paragraph 3 a (new)
До ...* Комисията следва да преразгледа разпоредбите на настоящия регламент относно защитата на данните от изпитвания и проучвания, свързани с гръбначни животни.
By ...* the Commission shall carry out a review of the provisions in this Regulation concerning data protection for tests and studies involving vertebrate animals.
Under this proposal the results from tests involving vertebrate animals enjoy data protection, but such data have to be shared.
Under this proposal the results from tests involving vertebrate animals enjoy data protection, but such data have to be shared.
This compromise is at present necessary for practical reasons (otherwise many new products will not be marketable), but should be evaluated in due course.
This compromise is at present necessary for practical reasons (otherwise many new products will not be marketable), but should be evaluated in due course.
Член 60, параграф 1 а (нов)
Article 60, paragraph 1 a (new)
След като на ищеца бъде дадена възможност да изложи позицията си, компетентният огран взема решение относно поверителността на информацията, което включва подходящо изложение на съображенията, на които то се основава.
After giving the claimant an opportunity to state his views, the competent authority shall adopt a decision on the confidentiality of the information, which shall contain an adequate statement of the reasons on which it is based.
Органът съобщава решението на ищеца.
It shall communicate the decision to the claimant.
Disclosing information can significantly impact commercial interests.
Disclosing information can significantly impact commercial interests.
Therefore, information owners must be given an opportunity to express their views on disclosure.
Therefore, information owners must be given an opportunity to express their views on disclosure.
Член 60, параграф 1, буква в а) (нова) и в б) (нова)
Article 60, paragraph 2, point (c a) (new) and (c b) (new)
вa) имената и личните данни на научни работници и лаборанти, отговарящи за провеждането на тестовете и проучванията, в които се използват гръбначни животни;
(ca) the names and personal details of scientists and laboratory assistants responsible for carrying out tests and studies in which use is made of vertebrate animals;
вб) информаиця за настоящи експерименти или тестове за изследователски или развойни цели, както е посочено в член 51.
(cb) information on current experiments or tests for research or development purposes, as defined in Article 51.
The confidentiality of information to protect commercial interests must be considered on a case-by-case basis in the light of the arguments put forward by the applicant concerned.
The confidentiality of information to protect commercial interests must be considered on a case-by-case basis in the light of the arguments put forward by the applicant concerned.
In any event, information on research and development is often highly sensitive and should therefore as a rule be treated in confidence.
In any event, information on research and development is often highly sensitive and should therefore as a rule be treated in confidence.
Laboratory assistants who carry out animal testing are often the target of attacks and their details must therefore be protected.
Laboratory assistants who carry out animal testing are often the target of attacks and their details must therefore be protected.
Засилено сътрудничество - Дата на обявяване в заседание
Enhanced cooperation - date announced in plenary
Šarūnas Birutis, Renato Brunetta, Jerzy Buzek, Jorgo Chatzimarkakis, Silvia Ciornei, Pilar del Castillo Vera, Lena Ek, Nicole Fontaine, Adam Gierek, Norbert Glante, Fiona Hall, David Hammerstein, Erna Hennicot-Schoepges, Mary Honeyball, Romana Jordan Cizelj, Romano Maria La Russa, Pia Elda Locatelli, Angelika Niebler, Reino Paasilinna, Miloslav Ransdorf, Vladimír Remek, Herbert Reul, Mechtild Rothe, Paul Rübig, Andres Tarand, Patrizia Toia, Catherine Trautmann, Claude Turmes, Nikolaos Vakalis, Alejo Vidal-Quadras
Šarūnas Birutis, Renato Brunetta, Jerzy Buzek, Jorgo Chatzimarkakis, Silvia Ciornei, Pilar del Castillo Vera, Lena Ek, Nicole Fontaine, Adam Gierek, Norbert Glante, Fiona Hall, David Hammerstein, Erna Hennicot-Schoepges, Mary Honeyball, Romana Jordan Cizelj, Romano Maria La Russa, Pia Elda Locatelli, Angelika Niebler, Reino Paasilinna, Miloslav Ransdorf, Vladimír Remek, Herbert Reul, Mechtild Rothe, Paul Rübig, Andres Tarand, Patrizia Toia, Catherine Trautmann, Claude Turmes, Nikolaos Vakalis, Alejo Vidal-Quadras
Pilar Ayuso, Dorette Corbey, Philip Dimitrov Dimitrov, Robert Goebbels, Cristina Gutiérrez-Cortines, Satu Hassi, Eija-Riitta Korhola, Erika Mann, John Purvis, Hannes Swoboda, Silvia-Adriana Ţicău
Pilar Ayuso, Dorette Corbey, Philip Dimitrov Dimitrov, Robert Goebbels, Cristina Gutiérrez-Cortines, Satu Hassi, Eija-Riitta Korhola, Erika Mann, John Purvis, Hannes Swoboda, Silvia-Adriana Ţicău
СТАНОВИЩЕ на Комисията по вътрешен пазар и защита на потребителите*
OPINION of the Committee on the Internal Market and Consumer Protection (*)
до Комисията по околна среда, здравеопазване и безопасност на храните
for the Committee on the Environment, Public Health and Food Safety
This proposed regulation is intended to replace Directive 91/414/EEC concerning the placing of plant protection products on the market and to repeal Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances.
This proposed regulation is intended to replace Directive 91/414/EEC concerning the placing of plant protection products on the market and to repeal Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances.
The use of plant protection products has an impact on agricultural eco-systems and can pose a health threat for users, impair the quality of food and have an adverse effect on consumer health if harmful residues of these products are found in food.
The use of plant protection products has an impact on agricultural eco-systems and can pose a health threat for users, impair the quality of food and have an adverse effect on consumer health if harmful residues of these products are found in food.
On the other hand, plant production products are used to protect and promote the health of crops and allow farmers to double their yield and plant crops more flexibly.
On the other hand, plant production products are used to protect and promote the health of crops and allow farmers to double their yield and plant crops more flexibly.
This ensures that agricultural produce can be produced locally, cheaply and reliably, reduces the area of land needed for food production and gives European countries a high degree of independence from agricultural imports.
This ensures that agricultural produce can be produced locally, cheaply and reliably, reduces the area of land needed for food production and gives European countries a high degree of independence from agricultural imports.
A key concern of the proposal is to increase the harmonisation of the approval of plant protection products throughout the EU, thereby further strengthening the internal market.
A key concern of the proposal is to increase the harmonisation of the approval of plant protection products throughout the EU, thereby further strengthening the internal market.
Your draftswoman supports the approach of introducing a procedure for obligatory zonal mutual recognition of approvals in Member States, in addition to the regular approval procedure, since this will avoid unnecessary duplication of effort in the Member States and ultimately lead to innovative and more environmentally-friendly plant protection products becoming more rapidly available.
Your draftswoman supports the approach of introducing a procedure for obligatory zonal mutual recognition of approvals in Member States, in addition to the regular approval procedure, since this will avoid unnecessary duplication of effort in the Member States and ultimately lead to innovative and more environmentally-friendly plant protection products becoming more rapidly available.
Furthermore, she proposes that under certain conditions interzonal mutual recognition of approvals, should also be possible.
Furthermore, she proposes that under certain conditions interzonal mutual recognition of approvals, should also be possible.
On the other hand, measures must be taken to ensure that agricultural and climatic differences between the Member States in a given zone are taken into account in issuing individual approvals.
On the other hand, measures must be taken to ensure that agricultural and climatic differences between the Member States in a given zone are taken into account in issuing individual approvals.
As regards data protection in respect of studies which must be submitted for the approval of plant protection products, your draftswoman proposes arrangements which will ensure the competitiveness of Europe's economy and the innovative capacity of plant producers engaged in research, while at the same time allowing the producers of generic products to access the market.
As regards data protection in respect of studies which must be submitted for the approval of plant protection products, your draftswoman proposes arrangements which will ensure the competitiveness of Europe’s economy and the innovative capacity of plant producers engaged in research, while at the same time allowing the producers of generic products to access the market.
In this context, particular attention is paid to special conditions relating to the approval of plant protection products and the active substances they contain, in particular the automatic expiry of first approvals after ten years.
In this context, particular attention is paid to special conditions relating to the approval of plant protection products and the active substances they contain, in particular the automatic expiry of first approvals after ten years.
Your draftswoman considers that legal provisions at EU level on parallel imports of plant protection measures are necessary.
Your draftswoman considers that legal provisions at EU level on parallel imports of plant protection measures are necessary.
There is great legal uncertainty at present due to conflicting court judgments and major differences in the ways in which Member States address imports.
There is great legal uncertainty at present due to conflicting court judgments and major differences in the ways in which Member States address imports.
Комисията по вътрешен пазар и защита на потребителите приканва водещата Комисия по околна среда, здравеопазване и безопасност на храните да включи в доклада си следните изменения:
The Committee on the Internal Market and Consumer Protection calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
Позоваване 1
Recital 1
Като взе предвид Договора за създаване на Европейската общност, и по-специално член 37, параграф 2 и член 152 параграф 4, буква б) от него,
Having regard to the Treaty establishing the European Community, and in particular Articles 37(2) and 152(4)(b) thereof,
Като взе предвид Договора за създаване на Европейската общност, и по-специално член 37, параграф 2 , член 152, параграф 4, буква б) и член 95, параграф 1 от него,
Having regard to the Treaty establishing the European Community, and in particular Articles 37(2) , 152(4)(b) and 95(1) thereof,
The purpose of the Regulation is to ensure the free movement of goods in the field of plant protection products in the common internal market by means of harmonised rules on the placing of such products on the market (see Recital (7) and Chapter III).
The purpose of the Regulation is to ensure the free movement of goods in the field of plant protection products in the common internal market by means of harmonised rules on the placing of such products on the market (see Recital (7) and Chapter III).
For this reason the Regulation should also have Article 95(1) TEC as its legal basis.
For this reason the Regulation should also have Article 95(1) TEC as its legal basis.
Целта на настоящия регламент е да осигури високо равнище на защита на здравето на хората и животните, както и на околната среда.
The purpose of this regulation is to ensure a high level of protection of both human and animal health and the environment.
Целта на настоящия регламент е също да хармонизира правилата за пускането на пазара на продукти за растителна защита с цел хармонизиране на достъпа до продукти за растителна защита на селскостопанските производители в различни държави-членки.
The purpose of this regulation is furthermore to harmonise the rules on the placing on the market of plant protection products in order to harmonise the availability of plant protection products between farmers in different Member States.
18. "добра растителнозащитна практика"
(18) ‘Good Plant Protection Practice’
Практика, при която обработката на определена култура с продукти за растителна защита, в съответствие с условията за тяхната разрешена употреба, се подбира, дозира и извършва във времето, така че да се гарантира оптимална ефикасност с минимално необходимо количество при надлежно отчитане на местните условия и възможностите за културен и биологичен контрол;
Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure optimum efficacy with the minimum quantity necessary, taking due account of local conditions and of the possibilities for cultural and biological control;
Практика, при която обработката на определена култура с продукти за растителна защита, в съответствие с условията за тяхната разрешена употреба, се подбира, дозира и извършва във времето, така че да се гарантира оптимална ефикасност с минимално необходимо количество при надлежно отчитане на местните условия, на нобходимостта да се предотврати изграждането на резистентност и възможностите за културен и биологичен контрол;
Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure optimum efficacy with the minimum quantity necessary, taking due account of local conditions , of the need to prevent the build-up of resistance and of the possibilities for cultural and biological control.
Prevention of the build-up of resistance therefore needs to be included in the definition of good plant protection practice.
Prevention of the build-up of resistance therefore needs to be included in the definition of good plant protection practice..
Член 3, точка 19
Article 3, point 19
(19) "добра екологична практика"
(19) ‘Good Environmental Practice’
This new definition is superfluous and would in practice lead to friction and problems of interpretation, since the requirement to use plant protection products in a way 'which only contaminates the environment with the smallest amount practicable' is already one of the main principles of good plant protection practice.
This new definition is superfluous and would in practice lead to friction and problems of interpretation, since the requirement to use plant protection products in a way ‘which only contaminates the environment with the smallest amount practicable’ is already one of the main principles of good plant protection practice.
Moreover, the new definition is too vague.
Moreover, the new definition is too vague.
Член 3, точка 22 (нова)
Article 3, point 22 (new)
(22) "добра експериментална практика"
(22) ‘Good Experimental Practice’
Практика, съответстваща на определението в Директива 2004/10/ЕО относно хармонизиране на законовите, подзаконовите и административните разпоредби, свързани с прилагането на принципите на добра лабораторна практика и верифицирането на тяхното прилагане при изпитвания на химически вещества; 1
Practice as defined by Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances; 1
Член 3, точка 23 (нова)
Article 3, point 23 (new)
(23) "изпитвания и проучвания"
(23) ‘Tests and studies’
Изследване или експеримент, чиято цел е да се определят свойствата и поведението на активно вещество или продукти за растителна защита, да се предвиди излагане на активни вещества и/или на съответните им метаболити, да се определят безопасните равнища на излагане и да се установят условията за безопасна употреба на продукти за растителна защита;
Investigation or experiment whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolities, determine safe levels of exposure and establish conditions for the safe use of plant protection products;
Test and study reports terminology is used repeatly throughout this regulation.
Test and study reports terminology is used repeatedly throughout this regulation.
Член 3, точка 24 (нова)
Article 3, point 24 (new)
(24) "добра селскостопанска практика"
(24) ‘Good Agricultural Practice’
Добрата селскостопанска практика при употребата на продукти за растителна защита включва разрешената на национално ниво безопасна употреба на продукти за растителна защита в съответствие с реалните условия за ефективен контрол на вредителите.
Good Agricultural Practice in the use of plant protection products (GAP) includes the nationally authorised safe uses of plant protection products under actual conditions necessary for effective pest control.
Тя обхваща широк набор от приложения на продукт за растителна защита до най-високото ниво на разрешена употреба, прилаган по начин, при който оставя след себе си възможно най-малко остатъчно количество.
It encompasses a range of levels of plant protection product applications up to the highest authorised use, applied in a manner which leaves the smallest practicable amount of residue .
Разрешените безопасни употреби се определят на национално ниво и включват регистрирани на национално ниво или препоръчителни употреби, които вземат под внимание съображения, свързани с общественото и професионалното здраве и с опазването на околната среда.
Authorised safe uses are determined at the national level and include nationally registered or recommended uses, which take into account public and occupational health and environmental safety considerations.
Реалните условия включват всеки етап от производството, съхранението, транспортирането, разпространението на хранителни продукти и животински фуражи.
Actual conditions include any stage in the production, storage, transport, distribution of food commodities and animal feed.
The Food and Agriculture Organisation's definition of 'good agricultural practice' should be incorporated into the Regulation.
The Food and Agriculture Organisation’s definition of ‘good agricultural practice’ should be incorporated into the Regulation.
Член 3, точка 25 (нова)
Article 3, point 25 (new)
(25) "маловажни употреби"
(25) ‘Minor uses’
Definition of the term 'minor uses´ used in Article 49.
Definition of the term ‘minor uses’ used in Article 49.
а) не оказват никакво вредно въздействие върху здравето на хората, в т.ч. уязвими групи, или върху здравето на животните, като се отчитат известните кумулативни и синергични въздействия, когато са налице методи за оценка на тези въздействия , или върху подпочвените води;
(a) they shall not have any harmful effects on human health , including vulnerable groups, or animal health, taking into account known cumulative and synergistic effects when the methods to assess such effects are available, or on ground water;