natgillin/translations-raw huggingface dataset:
As Codex values prejudge the establishment of MRLs in the Community, the Commission must involve the Council and the European Parliament before agreement is reached.
As Codex values prejudge the establishment of MRLs in the Community, the Commission must involve the Council and the European Parliament before agreement is reached.
Automatically incorporating decisions in which the public, Member States and the European Parliament were not formally involved via the codecision procedure should be avoided, not least in the light of previous experience.
Automatically incorporating decisions in which the public, Member States and the European Parliament were not formally involved via the codecision procedure should be avoided, not least in the light of previous experience.
As regards general issues related to assessment, account should be taken of the fact that, essentially, MRLs are of relevance to food legislation.
As regards general issues related to assessment, account should be taken of the fact that, essentially, MRLs are of relevance to food legislation.
Therefore, when it comes to the risk assessment, the same aspects as in other areas of food legislation must be taken into account.
Therefore, when it comes to the risk assessment, the same aspects as in other areas of food legislation must be taken into account.
Particular consideration should be given to protecting vulnerable categories of people and the possibility of cumulative effects.
Particular consideration should be given to protecting vulnerable categories of people and the possibility of cumulative effects.
In the interests of improving the manageability and transparency of rules for inspectors, it would appear sensible to set MRLs for substances not used in veterinary medicinal products but that have a similar effect and for substances used mainly abroad that are placed on the market here via animal products.
In the interests of improving the manageability and transparency of rules for inspectors, it would appear sensible to set MRLs for substances not used in veterinary medicinal products but that have a similar effect and for substances used mainly abroad that are placed on the market here via animal products.
Trade aspects and easing the administrative burden should, however, always be secondary to health protection.
Trade aspects and easing the administrative burden should, however, always be secondary to health protection.
The rapporteur also proposes rules on how to treat pharmacologically active substances for which no limits have been set.
The rapporteur also proposes rules on how to treat pharmacologically active substances for which no limits have been set.
Essentially, the proposals correspond to the earlier rules laid down in Regulation (ECC) No 315/93.
Essentially, the proposals correspond to the earlier rules laid down in Regulation (ECC) No 315/93.
The European Parliament’s right to be involved when rules on assessment are set must therefore be more widely applied than is proposed by the Commission proposal.
The European Parliament’s right to be involved when rules on assessment are set must therefore be more widely applied than is proposed by the Commission proposal.
Comisia pentru agricultură şi dezvoltare rurală solicită Comisiei pentru mediu, sănătate publică şi siguranţă alimentară, competentă în fond, să includă în raportul său următoarele amendamente:
The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
(a) concentraţia maximă a unui reziduu al unei substanţe farmacologic active care poate fi autorizată în alimentele de origine animală („limita maximă a reziduurilor”);
(a) the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (“maximum residue limit”);
(a) concentraţia maximă într-un produs veterinar a unui reziduu al unei substanţe farmacologic active care poate fi autorizată în alimentele de origine animală („limita maximă a reziduurilor”);
(a) the maximum concentration of a residue of a pharmacologically active substance contained in a veterinary product which may be permitted in food of animal origin (“maximum residue limit”);
The substances affected by this regulation constitute a large group, all of them being pharmacologically active in a specific fashion.
The substances affected by this regulation constitute a large group, all of them being pharmacologically active in a specific fashion.
However, the procedures defined later in this text differentiate clearly between those contained in veterinary medicines and those intended for other uses.
However, the procedures defined later in this text differentiate clearly between those contained in veterinary medicines and those intended for other uses.
These two types should therefore be defined as distinct entities from the outset.
These two types should therefore be defined as distinct entities from the outset.
Articolul 1 alineatul (1) litera (aa) (nouă)
Article 1, paragraph 1, point (a a) (new)
(aa) concentraţia maximă în produsele biocide utilizate în creşterea animalelor a unui reziduu al unei substanţe active care este autorizată în alimentele de origine animală;
( aa ) the maximum concentration of a residue of an active substance contained in biocidal products used in stockbreeding which are permitted in foodstuffs of animal origin;
This regulation affects a large group of substances, all of them pharmacologically active in a specific fashion.
This regulation affects a large group of substances, all of them pharmacologically active in a specific fashion.
It is therefore desirable to delimit those substances not included in veterinary medicines which are affected by it.
It is therefore desirable to delimit those substances not included in veterinary medicines which are affected by it.
For these, it is preferable to refer to 'active substances', reserving the term 'pharmacologically active' for those intended for the preparation of medicines, in line with the Community legislation on pharmaceuticals.
For these, it is preferable to refer to 'active substances', reserving the term 'pharmacologically active' for those intended for the preparation of medicines, in line with the Community legislation on pharmaceuticals.
În vederea garantării disponibilității produselor medicinale veterinare autorizate în condiții care afectează speciile producătoare de alimente, cu ocazia realizării evaluărilor științifice ale riscurilor și a formulării recomandărilor de gestionare a riscurilor, comitetul intenționează să utilizeze limitele maxime ale reziduurilor stabilite pentru substanțele farmacologic active într- un produs alimentar anume sau pentru alte alimente derivate din aceeași specie sau într- una sau mai multe specii pentru specii diferite.
With a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing species, the Committee shall, when carrying out scientific risk assessments and when drawing up risk management recommendations, consider using maximum residue limits established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or in one or more species for other species.
În conformitate cu obiectivele de asigurare a unui nivel ridicat de protecţie a sănătăţii şi cu principiile enunţate la articolul 6, în vederea garantării disponibilităţii produselor medicinale veterinare autorizate în condiţii care afectează speciile producătoare de alimente, cu ocazia realizării evaluărilor ştiinţifice ale riscurilor şi a formulării recomandărilor de gestionare a riscurilor, comitetul intenţionează să utilizeze :
In line with the objective of ensuring a high level of health protection and with the principles laid down in Article 6, the Committee shall, with a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing species, when carrying out scientific risk assessments and when drawing up risk management recommendations, consider using :
(a) limitele maxime ale reziduurilor stabilite pentru un produs alimentar anume sau pentru alte alimente derivate din aceeaşi specie,
(a) maximum residue limits established in relation to a particular foodstuff for another foodstuff derived from the same species,
(b) limitele maxime ale reziduurilor stabilite pentru una sau mai multe specii pentru specii diferite.
(b) maximum residue limits established in relation to one or more species for other species.
Evaluarea științifică a riscurilor ia în considerare metabolismul și epuizarea substanțelor farmacologic active în cazul speciilor de animale vizate și tipul de reziduuri și cantitatea acestora care poate fi ingerată de către oameni pe parcursul unei vieți fără un important risc al sănătății exprimat în doză zilnică acceptabilă (DZA) .
The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species and the type of residues, and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily intake (ADI).
Evaluarea ştiinţifică a riscurilor ia în considerare metabolismul şi epuizarea substanţelor farmacologic active în cazul speciilor de animale diferite şi tipul de reziduuri şi cantitatea acestora care poate fi ingerată de către oameni pe parcursul unei vieţi fără un important risc asupra sănătăţii exprimat în ingestie zilnică acceptabilă (IZA) .
The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in different animal species and the type of residues, and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily ingestion (ADI).
Pot fi utilizate abordări alternative la IZA dacă au fost stabilite de către comisie conform dispozițiilor din articolul 12 primul alineat.
Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 12(1).
The use of 'ingestion' rather than 'intake' is more consistent with the terminology used in this field.
The use of 'ingestion' rather than 'intake' is more consistent with the terminology used in this field.
It is preferable to refer to 'different' rather than 'relevant' animal species since this is broader and the soundness of the generalisation implied by extrapolation will be the greater the larger the number of species taken into account.
It is preferable to refer to 'different' rather than 'relevant' animal species since this is broader and the soundness of the generalisation implied by extrapolation will be the greater the larger the number of species taken into account.
(b) riscul efectelor farmacologice sau microbiologice în cazul oamenilor;
(b) the risk of pharmacological or microbiological effects in human beings;
The presence of residues of medicines (or other substances governed by this legislation) in foodstuffs is accidental and unintended.
The presence of residues of medicines (or other substances governed by this legislation) in foodstuffs is accidental and unintended.
There is therefore no reason to make a distinction between intended and unintended effects, as all will be unintended.
There is therefore no reason to make a distinction between intended and unintended effects, as all will be unintended.
Dacă metabolismul și epuizarea substanței nu pot fi evaluate și utilizarea substanței este destinată ameliorării sănătății și bunăstării animalelor, evaluarea științifică a riscurilor poate lua în considerare informațiile privind controlul sau cele privind expunerea.
If the metabolism and depletion of the substance cannot be assessed and the use of the substance is designed to promote animal health and welfare , the scientific risk assessment may take into account monitoring data or exposure data.
Dacă metabolismul şi epuizarea substanţei nu pot fi evaluate, evaluarea ştiinţifică a riscurilor poate lua în considerare informaţiile privind controlul sau cele privind expunerea.
If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.
The words 'and the use of the substance is designed to promote animal health and welfare' are redundant, since all the substances concerned are intended for at least one of those purposes.
The words 'and the use of the substance is designed to promote animal health and welfare' are redundant, since all the substances concerned are intended for at least one of those purposes.
Articolul 7 litera (c)
Article 7, point (c)
(c) eventuala necesitate de a stabili o limită maximă a reziduurilor sau o limită maximă provizorie a reziduurilor pentru o substanță farmacologic activă în produsele medicamentoase veterinare ale cărei reziduuri au fost găsite într-un aliment anume de origine animală, nivelul acelei limite maxime a reziduului și unde este cazul orice condiții sau restricții pentru utilizarea substanței vizate;
(c) whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products, residues of which have been found in a particular foodstuff of animal origin, the level of that maximum residue limit and, where appropriate, any conditions or restrictions for the use of the substance concerned;
(c) eventuala necesitate de a stabili o limită maximă a reziduurilor sau o limită maximă provizorie a reziduurilor pentru o substanţă farmacologic activă în produsele medicamentoase veterinare şi, unde este cazul, orice condiţii sau restricţii pentru utilizarea substanţei vizate;
(c) whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products, and, where appropriate, any conditions or restrictions for the use of the substance concerned;
[The first part of this amendment does not affect the English version].
[The first part of this amendment does not affect the English version].
This amendment deletes an unnecessary specification, since the presence of residues and the fixing of a tolerance threshold constitute the raison d'être as such of the MRLs.
This amendment deletes an unnecessary specification, since the presence of residues and the fixing of a tolerance threshold constitute the raison d'être as such of the MRLs.
Articolul 7 litera (da) (nouă)
Article 7, point (d a) (new)
(da) posibilitatea depunerii de recomandări în scopul de a contribui la stabilirea unor perioade de aşteptare pentru alte specii producătoare de alimente, atunci când este necesară utilizarea sistemului în cascadă.
( da ) the feasibility of submitting recommendations aimed at contributing to establishing withdrawal periods for other food-producing species where it is necessary to use the cascade system.
[not translated: over-length - see instructions from Planning on Fdr]
[ not translated: over-length - see instructions from Planning on Fdr ]
Articolul 8 alineatul (4a) (nou)
Article 8, paragraph 4 a (new)
(4a) În cazuri specifice, care necesită o autorizare urgentă, în scopul de a se garanta protejarea sănătăţii umane şi a sănătăţii şi bunăstării animalelor, Comisia poate stabili o limită maximă provizorie a reziduurilor pentru o perioadă care nu poate depăşi cinci ani, urmând procedura de reglementare cu control prevăzută la articolul 21 alineatul (3).
In specific cases where urgent authorisation is required to ensure the protection of human health and animal health and welfare, the Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 21(3), establish a provisional maximum residue limit for a period not exceeding five years.
Titlul II capitolul 1 secţiunea 2 titlu
Title II, Chapter 1, Section 2, title
Substanţe farmacologic active care nu sunt destinate pentru medicamentele de uz veterinar
Pharmacologically active substances not intended for use in veterinary medicinal products
Substanţe farmacologic active care nu sunt destinate medicamentelor de uz veterinar şi alte substanţe active care nu sunt incluse în Secţiunea 1
Pharmacologically active substances not intended for use in veterinary medicinal products and other active substances not included in Section 1
The title is changed in line with other amendments tabled.
The title is changed in line with other amendments tabled.
Articolul 9 alineatul (1) primul paragraf
Article 9, paragraph 1, subparagraph 1
Pentru substanţele care nu sunt destinate utilizării pentru medicamente de uz veterinar, care se vor introduce pe piaţă în Comunitate şi în cazul în care nu s-a depus nici o cerere pentru astfel de substanţe, în conformitate cu articolul 3, Comisia, statele membre sau o entitate terţă care are interese legitime, pot transmite Agenţiei cereri pentru un aviz cu privire la limitele maxime de reziduuri.
For substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made in accordance with Article 3, the Commission , Member States or a third party pursuing legitimate interests may forward to the Agency requests for an opinion on maximum residue limits.
Paragraph 3 suggests that third parties may also forward requests, although this possibility is not included in paragraph 1.
Paragraph 3 suggests that third parties may also forward requests, although this possibility is not included in paragraph 1.
Systematic clarification.
Systematic clarification.
Articolul 13 titlu
Article 13, title
Clasificarea substanțelor farmacologic active
Classification of pharmacologically active substances
Clasificarea substanţelor active
Classification of active substances
This is in line with the amendments on Article 1.
This is in line with the amendments on Article 1.
Comisia clasifică substanțele farmacologic active care fac obiectul unui aviz cu privire la limita maximă a reziduurilor al Agenției, în conformitate cu articolele 4, 9 și 10.
The Commission shall classify the pharmacologically active substances subject to an opinion of the Agency on the maximum residue limit in accordance with Articles 4, 9 or 10.
Comisia clasifică substanţele active care fac obiectul unui aviz cu privire la limita maximă a reziduurilor al Agenţiei, în conformitate cu articolele 4, 9 şi 10.
The Commission shall classify the active substances subject to an opinion of the Agency on the maximum residue limit in accordance with Articles 4, 9 or 10.
(Această modificare se aplică întregului articol.
(This amendment applies to the entire article.
Adoptarea sa impune adaptări tehnice în ansamblul textului. )
Its adoption will require technical modifications throughout the article. )
To ensure consistency with the amendment tabled to Article 1(1) adding a new point (aa), and to make it clear that this article should apply to all the substances cited in that Article 1, it is desirable to delete 'pharmacologically'.
To ensure consistency with the amendment tabled to Article 1(1) adding a new point (aa), and to make it clear that this article should apply to all the substances cited in that Article 1, it is desirable to delete 'pharmacologically'.
O limită maximă provizorie a reziduurilor poate fi stabilită pentru o substanţă farmacologic activă chiar dacă datele ştiinţifice sunt incomplete, cu condiţia să nu fie motive pentru a presupune că reziduurile substanţei respective, la limita propusă, prezintă un risc pentru sănătatea umană.
A provisional maximum residue limit may be established for an active substance in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a risk to human health.
Evaluarea riscului trebuie efectuată în conformitate cu principiile enunţate la articolul 6 şi cu reglementările prevăzute la articolul 12.
The decision on risk must be based on the principles referred to in Article 6 and the rules laid down in Article 12.
Limita maximă provizorie a reziduurilor se aplică pentru un termen limitat, care nu poate depăși 5 ani .
The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years .
Acest termen poate fi prorogat o dată, pentru o perioadă care nu poate depăși doi ani, dacă se demonstrează că o asemenea prorogare permite cercetărilor științifice în curs să fie terminate.
That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow scientific studies in progress to be completed.
Limita maximă provizorie a reziduurilor se aplică pentru un termen limitat, care nu poate depăşi trei ani .
The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed three years .
The maximum period of five years for provisional authorisation would appear too long.
The maximum period of five years for provisional authorisation would appear too long.
As a rule, the substances involved have undergone an authorisation or other test procedure, meaning that the required results would have to be available within three years.
As a rule, the substances involved have undergone an authorisation or other test procedure, meaning that the required results would have to be available within three years.
This is a longer time period than for setting limits under the normal procedure.
This is a longer time period than for setting limits under the normal procedure.
(a) dacă utilizarea unei substanţe active pentru animalele de la care se obţin produse alimentare reprezintă un risc pentru sănătatea umană;
(a) where any use of an active substance in food-producing animals constitutes a risk to human health;
Statele membre nu pot să interzică sau să îngrădească importurile și punerea pe piață a produselor alimentare de origine animală din motive referitoare la limitele maxime ale reziduurilor dacă dispozițiile prezentului regulament și normele de punere în aplicare a acestuia au fost respectate.
Member States may not prohibit or impede the import and placing on the market of food of animal origin on grounds related to maximum residue limits where the provisions of this Regulation and its implementing measures have been complied with.
Statele membre nu pot să interzică sau să îngrădească importurile şi punerea pe piaţă a produselor alimentare de origine animală din motive referitoare la limitele maxime ale reziduurilor sau la cadrul de referinţă dacă dispoziţiile prezentului regulament şi normele de aplicare a acestuia au fost respectate.
Member States may not prohibit or impede the import and placing on the market of food of animal origin on grounds related to maximum residue limits or reference points for action where the provisions of this Regulation and its implementing measures have been complied with.
This regulation establishes two indices related to the health standards of foodstuffs in the context of the presence of other substances, namely MRLs and reference points for action.
This regulation establishes two indices related to the health standards of foodstuffs in the context of the presence of other substances, namely MRLs and reference points for action.
Foodstuffs of animal origin which do not exceed the threshold under whichever index supplies shall be considered safe and may move freely, with no obstacles related to residues.
Foodstuffs of animal origin which do not exceed the threshold under whichever index supplies shall be considered safe and may move freely, with no obstacles related to residues.
Article 16 should deal with freedom of movement in relation to both indices and not just to MRLs.
Article 16 should deal with freedom of movement in relation to both indices and not just to MRLs.
Articolul 18 alineatul (1)
Article 18, paragraph 1