natgillin/translations-raw huggingface dataset:
Evaluarea riscului ține seama de normele care vor fi adoptate de către Comisie, inclusiv metodele ştiinţifice, cu consultarea Autorității Europene pentru Siguranța Alimentelor.
The risk assessment shall take account of rules including scientific methods to be adopted by the Commission in consultation with the European Food Safety Authority.
Risk assessment which is the responsibility of EFSA concerns scientific opinion, methods and procedures.
Risk assessment which is the responsibility of EFSA concerns scientific opinion, methods and procedures.
It is unclear what is meant by rules.
It is unclear what is meant by rules.
Introducerea pe piaţă
Placing on the market
Produsul nu este introdus pe piaţă ca aliment, prelucrat în vederea producerii de alimente sau amestecat cu alte alimente dacă se depăşesc limitele maxime ale reziduurilor sau cantităţile de referinţă stabilite în conformitate cu prezentul regulament.
If the maximum residue limits or reference quantities established under this Regulation are exceeded, the product shall not be placed on the market as a foodstuff, transformed into foodstuffs or mixed with foodstuffs.
There should be legal consequences for exceeding limits or reference quantities.
There should be legal consequences for exceeding limits or reference quantities.
A ban on marketing and mixing would appear to be the appropriate measure and relieves the inspecting authorities from making a decision on the ground.
A ban on marketing and mixing would appear to be the appropriate measure and relieves the inspecting authorities from making a decision on the ground.
Implementarea cadrelor de referinţă
Implementing reference points for action
În cazul în care alimentele de origine animală sunt supuse unor controale, iar rezultatul testelor analitice confirmă prezenţa, la un nivel egal sau superior cadrului său de referinţă, a unei substanţe farmacologic active care nu face obiectul unei clasificări în conformitate cu articolul 13 alineatul (2) litera (a), (b) sau (c), lotul în cauză este considerat neconform cu legislaţia comunitară.
Where checks are carried out on food of animal origin and the results of analytical tests confirm the presence of a pharmacologically active substance which is not subject to a classification in accordance with Article 13(2 )( a), (b) or (c) at a level equal to or higher than its reference point for action, the relevant batch shall be deemed not to comply with Community legislation.
Introducerea produselor în lanţul alimentar este autorizată în cazul în care rezultatele testelor analitice efectuate asupra alimentelor de origine animală indică valori inferioare cadrului de referinţă.
Where the results of analytical tests carried out on food of animal origin are below the reference points for action, the product's entry into the food chain shall be authorised.
Autoritatea competentă păstrează o evidenţă a rezultatelor în caz de recurenţă.
The competent authority shall retain a record of the findings in case of recurrence.
În cazul în care rezultatele testelor analitice efectuate asupra produselor având aceeaşi origine indică un model recurent care sugerează o problemă potenţială, autoritatea competentă informează Comisia şi celelalte state membre în cadrul Comitetului permanent pentru lanţul alimentar şi sănătatea animală cu privire la aceasta.
Where the results of analytical tests on products from the same origin show a recurrent pattern indicating a potential problem, the competent authority shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health.
Comisia aduce problema în atenţia autorităţii competente din ţara sau din ţările de origine şi prezintă propuneri corespunzătoare.
The Commission shall bring the matter to the attention of the competent authority of the country or countries of origin and shall submit appropriate proposals.
Detaliile acestor măsuri sunt stabilite în conformitate cu procedura de reglementare cu control menţionată la articolul 21 alineatul (3).
Detailed rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).
În termen de [60] de zile de la intrarea în vigoare a prezentului regulament, Comisia adoptă, în conformitate cu procedura de reglementare prevăzută la articolul 20 alineatul (2) , un regulament conținând substanțele farmacologic active și clasificarea acestora cu privire la limitele maxime ale reziduurilor, în conformitate cu anexele I și IV ale Regulamentului (CEE) nr.
Within [ 60 ] days after the entry into force of this Regulation, the Commission shall adopt, in accordance with the regulatory procedure referred to in Article 20(2) , a Regulation containing the pharmacologically active substances and their classification regarding maximum residues limits in accordance with Annexes I to IV of Regulation (EEC) No 2377/90.
This relates to the adoption of the annexe to this regulation.
This relates to the adoption of the annexe to this regulation.
The regulatory procedure with scrutiny should be applied in this case.
The regulatory procedure with scrutiny should be applied in this case.
Articolul 22a (nou)
Article 22 a (new )
Raport prezentat Parlamentului European şi Consiliului
Report to the European Parliament and the Council
În termen de cel mult cinci ani de la intrarea în vigoare a prezentului regulament, Comisia prezintă un raport Parlamentului European şi Consiliului.
The Commission shall, not later than five years after the entry into force of this Regulation, submit a report to the European Parliament and the Council.
Raportul analizează, în special, experienţa acumulată prin punerea în aplicare a prezentului regulament.
The report shall, in particular, review the experience gained from the application of this Regulation.
În cazul în care este necesar, raportul va fi însoţit de propuneri corespunzătoare.
The report shall, if appropriate, be accompanied by relevant proposals.
Veterinary medicinal products used for the therapeutic treatment and the welfare of animals, which are destined for human consumption, may give rise to residues of such products in food-producing animals.
Veterinary medicinal products used for the therapeutic treatment and the welfare of animals, which are destined for human consumption, may give rise to residues of such products in food-producing animals.
This proposed repeal Regulation of the procedure on maximum residue levels defines food producing animals as "animals bred, raised, kept, slaughtered or harvested specifically for the purpose of the producing food."
This proposed repeal Regulation of the procedure on maximum residue levels defines food producing animals as "animals bred, raised, kept, slaughtered or harvested specifically for the purpose of the producing food."
In order to ensure public health and consumer safety, a risk assessment
In order to ensure public health and consumer safety, a risk assessment
Risk assessment is a science-based approach; the purpose is the assessment of the known or potential adverse effects on health from exposure to food-borne hazards, in this case human exposure to veterinary drug residues. of the safety limit of residues of all pharmacologically active substances contained in veterinary products has to be carried out.
Risk assessment is a science-based approach; the purpose is the assessment of the known or potential adverse effects on health from exposure to food-borne hazards, in this case human exposure to veterinary drug residues. of the safety limit of residues of all pharmacologically active substances contained in veterinary products has to be carried out.
This is in accordance with the existing legislation Council Regulation EEC No 2377/90.
This is in accordance with the existing legislation Council Regulation EEC No 2377/90.
Existing Council Regulation 2377/90 lays down that maximum residue limits (MRLs) be established for all such active substances, where appropriate.
Existing Council Regulation 2377/90 lays down that maximum residue limits (MRLs) be established for all such active substances, where appropriate.
The Commission's proposal to repeal Regulation 2377/90 seeks to resolve the difficulties encountered in the application of this existing legislation.
The Commission's proposal to repeal Regulation 2377/90 seeks to resolve the difficulties encountered in the application of this existing legislation.
It proposes much needed alternative ways to achieve a high level of consumer protection, coupled with the continued availability and development of veterinary medicinal products for the European market and good functioning of the intra- and extra- Community trade in food of animal origin.
It proposes much needed alternative ways to achieve a high level of consumer protection, coupled with the continued availability and development of veterinary medicinal products for the European market and good functioning of the intra- and extra- Community trade in food of animal origin.
As the ultimate goal is human health protection, a more consistent approach is required for the risk analysis and control of residues of pharmacologically active substances, which may appear in food produced in or imported into the European Union.
As the ultimate goal is human health protection, a more consistent approach is required for the risk analysis and control of residues of pharmacologically active substances, which may appear in food produced in or imported into the European Union.
Problems with the current legislation for the setting of MRLs:
Problems with the current legislation for the setting of MRLs :
The Commission rightly points out that the current legislation has led to a serious decrease in veterinary medicines "to an extent that creates adverse effects for public and animal health and animal welfare".
The Commission rightly points out that the current legislation has led to a serious decrease in veterinary medicines "to an extent that creates adverse effects for public and animal health and animal welfare".
The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMEA), agree that there are an insufficient number of medicinal products available for the therapeutic treatment and welfare of animals.
The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMEA), agree that there are an insufficient number of medicinal products available for the therapeutic treatment and welfare of animals.
This is particularly alarming for certain minor use and minor species such as sheep and horses, bees and fish.
This is particularly alarming for certain minor use and minor species such as sheep and horses, bees and fish.
As a result of this, there is a major deficiency of authorised medicines and the "off-label" use of products is increasing, which may jeopardise effective residue control with serious implications for consumer safety.
As a result of this, there is a major deficiency of authorised medicines and the "off-label" use of products is increasing, which may jeopardise effective residue control with serious implications for consumer safety.
There is also serious concern within the veterinary profession at the increasing therapeutic void resulting from the loss of essential substances with the added risks for animal health and welfare, which may also compromise the safe supply of animal protein for the human food chain.
There is also serious concern within the veterinary profession at the increasing therapeutic void resulting from the loss of essential substances with the added risks for animal health and welfare, which may also compromise the safe supply of animal protein for the human food chain.
Other problems that arise with Regulation 2377/90:
Other problems that arise with Regulation 2377/90:
· Standardele internaționale susținute de către UE nu pot fi introduse în legislația comunitară fără o nouă evaluare științifică de către Agenția Europeană pentru Medicamente.
· International standards supported by the EU cannot be included in Community legislation without a new scientific assessment by the European Medicines Agency.
· Serviciile de control ale statelor membre nu dispun de cadre de referință, în special pentru substanțele detectate în alimente de proveniență din țări terțe.
· Control services of Member States have no points of reference in particular for substances detected in food from third countries.
· The current legislation is hard to follow.
· The current legislation is hard to follow.
The proposed solution:
The proposed solution:
The proposal for repeal of Regulation 2377/90 addresses the shortcomings of the current situation by amending the existing legal framework on MRLs while leaving in place the overall system of setting MRLs based on scientific assessment.
The proposal for repeal of Regulation 2377/90 addresses the shortcomings of the current situation by amending the existing legal framework on MRLs while leaving in place the overall system of setting MRLs based on scientific assessment.
The main changes proposed are to:
The main changes proposed are to:
· Make the assessment of possibilities for extrapolation
· Make the assessment of possibilities for extrapolation
i.e. whereby under certain conditions the MRL fixed for a substance for one or more species can be applied to additional species without the need to replicate the fundamental scientific research.
i.e. whereby under certain conditions the MRL fixed for a substance for one or more species can be applied to additional species without the need to replicate the fundamental scientific research.
For example, foodstuff ð foodstuff: sheep muscle to sheep kidney and species ð species: sheep to goats. a compulsory part of the overall scientific assessment and create a legal basis for the Commission to lay down the principles for applying extrapolation.
For example, foodstuff ð foodstuff: sheep muscle to sheep kidney and species ð species: sheep to goats. a compulsory part of the overall scientific assessment and create a legal basis for the Commission to lay down the principles for applying extrapolation.
This will encourage the development of drugs to cover minor food-producing animals and thereby diminish the risk to public health from "off-label" use of drugs.
This will encourage the development of drugs to cover minor food-producing animals and thereby diminish the risk to public health from "off-label" use of drugs.
It will also reduce the development costs of new drugs without changing the existing high safety margins for public health.
It will also reduce the development costs of new drugs without changing the existing high safety margins for public health.
· Introduce an obligation to adapt Community legislation to include MRLs set at Codex Alimentarius
· Introduce an obligation to adapt Community legislation to include MRLs set at Codex Alimentarius
The Codex Alimentarius Commission of the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO), develops food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. with the support of the EU, thus reducing additional and unnecessary assessments.
The Codex Alimentarius Commission of the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO), develops food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. with the support of the EU, thus reducing additional and unnecessary assessments.
· Create a specific legal framework to set MRLs for pharmacologically active substances not intended to be authorised as veterinary medicines, in particular for control purposes and for imported food.
· Create a specific legal framework to set MRLs for pharmacologically active substances not intended to be authorised as veterinary medicines, in particular for control purposes and for imported food.
To achieve this, the proposal ensures Minimum Required Performance limits (MRPLs)
To achieve this, the proposal ensures Minimum Required Performance limits (MRPLs)
MRPLs were first introduced in Commission Decision 2005/34/EC laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries.
MRPLs were first introduced in Commission Decision 2005/34/EC laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries.
(control tools based on expert advice that are used as reference points for action at border inspection) are based on a sounder legal footing thus improving consumer protection and the functioning of the Single Market.
(control tools based on expert advice that are used as reference points for action at border inspection) are based on a sounder legal footing thus improving consumer protection and the functioning of the Single Market.
· Rearrange the sequence of articles in order to create a logical structure, differentiating in particular risk assessment from risk management provisions, to comply with the objective of "Better Regulation."
· Rearrange the sequence of articles in order to create a logical structure, differentiating in particular risk assessment from risk management provisions, to comply with the objective of "Better Regulation."
· Integrate into this proposed regulation the rules (MRLs, conditions of use, prohibitions) relating to individual substances, which are currently in 4 annexes of the current Regulation - again part of Better Regulation and simplification.
· Integrate into this proposed regulation the rules (MRLs, conditions of use, prohibitions) relating to individual substances, which are currently in 4 annexes of the current Regulation - again part of Better Regulation and simplification.
Despite the missed opportunity for greater consolidation of the relevant existing legislation, I very much welcome the proposed solution to ensure greater protection of human health and greater availability of veterinary medicines, seeing it as a long-overdue improvement in the current system for the setting of MRLs.
Despite the missed opportunity for greater consolidation of the relevant existing legislation, I very much welcome the proposed solution to ensure greater protection of human health and greater availability of veterinary medicines, seeing it as a long-overdue improvement in the current system for the setting of MRLs.
The amendments I have proposed are mainly for clarification and do not intend to substantially modify the Commission proposal.
The amendments I have proposed are mainly for clarification and do not intend to substantially modify the Commission proposal.
Domnule președinte,
Dear Mr Chairman,
Prin scrisoarea dumneavoastră din 26 martie 2008, ați sesizat Comisia pentru afaceri juridice, în conformitate cu articolul 35 alineatul (2) din Regulamentul de procedură, pentru examinarea validității și pertinenței temeiului juridic al susmenționatei propuneri a Comisiei.
By letter of 26 March 2008 you asked the Committee on Legal Affairs pursuant to Rule 35(2), to consider whether the legal basis of the above Commission proposal was valid and appropriate.
Comisia pentru afaceri juridice a examinat chestiunea mai sus menționată în cursul reuniunii sale din 8 aprilie 2008.
The committee considered the above question at its meeting of 8 April 2008.
Președintele Comisiei pentru mediu, sănătate publică și siguranță alimentară, Miroslav
The Chairman of the Committee on the Environment, Public Health and Food Safety, Miroslav
Ouzký , i-a adresat o scrisoare președintelui Comisiei pentru afaceri juridice, datată 26 martie 2008, în următorii termeni:
Ouzký , has written a letter to the Chairman of the Legal Affairs Committee dated 26 March 2008 in the following terms:
„Comisia pentru mediu, sănătate publică și siguranță alimentară examinează în prezent o propunere de regulament privind stabilirea limitelor reziduurilor substanțelor farmacologic active în alimentele de origine animală ( COM(2007)0194 ).
"The Committee on the Environment, Public Health and Food Safety is currently considering a proposal for a Regulation on establishment of residue limits of pharmacologically active substances in foodstuffs ( COM(2007)0194 ).
Propunerea are un dublu temei juridic, articolul 37 și articolul 152 alineatul (4) din Tratatul CE.
The proposal has a dual legal basis, Article 37 and Article 152(4) of the EC Treaty.
Raportoarea, doamna Doyle, a depus un amendament la propunere, în sensul eliminării articolului 37 ca temei juridic, considerând că articolul 152 alineatul (4) asigură un temei juridic adecvat și suficient și că un temei juridic dual nu poate fi justificat decât în cazul în care unul dintre cele două obiective nu îi este secundar celuilalt, situație inexistentă potrivit termenilor considerentului 26.
The rapporteur, Mrs Doyle, has tabled an amendment to the proposal deleting Article 37 as legal basis, as she considers that Article 152(4) provides an appropriate and a sufficient legal basis and that a dual legal basis can only be justified if one of the two objectives is not secondary to the other which is not the case according to the terms of recital 26.
Având în vedere cele de mai sus, aș dori să solicit Comisiei dumneavoastră parlamentare să furnizeze un aviz privind măsura în care temeiul juridic pentru această propunere este adecvat, în conformitate cu articolul 35 alineatul (2) din Regulamentul de procedură.
In view of the above, I would like to request your Committee to provide an opinion on the appropriateness of the legal basis for this proposal, pursuant to Rule 35(2) of the Rules of Procedure.
V-aș fi recunoscător dacă acest aviz ar putea fi comunicat până în data de 2 mai 2008, având în vedere faptul că votul din cadrul Comisiei pentru mediu, sănătate publică și siguranță alimentară asupra proiectului de raport este programat pentru 6 mai 2008.”
I would greatly appreciate it if this opinion could be made available by 2 May 2008, in view of the vote on the draft report in the Environment Committee, currently scheduled for 6 May 2008."
De fapt, Comisia propune drept temei juridic articolul 37 și articolul 152 alineatul (4) litera (b) din tratat, în vreme ce doamna Doyle propune drept temei juridic exclusiv articolul 152 alineatul (4) litera (b).
In point of fact, the Commission proposes that the legal basis should be Article 37 and Article 152(4)(b) of the Treaty, whereas Mrs Doyle is proposing that it should be Article 152(4)(b) alone.
Se observă faptul că, în justificarea amendamentului propus, raportoarea afirmă că „În acest caz, sănătatea publică reprezintă în mod clar obiectivul dominant (a se vedea considerentul 26), fapt ce face articolul 37 inesențial și chiar redundant ca temei juridic”.
It is noted that in the justification to her amendment, the rapporteur states that "In this case public health is clearly the dominating objective (see recital 26), which makes Article 37 non-essential and even redundant as a legal basis".
Temeiurile juridice în discuție :
The legal bases under consideration :
În vederea trasării liniilor directoare ale unei politici agricole comune, Comisia convoacă, după intrarea în vigoare a prezentului tratat, o conferință a statelor membre pentru a compara politicile lor agricole și pentru a stabili în special bilanțul resurselor și al necesităților acestora.
In order to evolve the broad lines of a common agricultural policy, the Commission shall, immediately this Treaty enters into force, convene a conference of the Member States with a view to making a comparison of their agricultural policies, in particular by producing a statement of their resources and needs.