natgillin/translations-raw huggingface dataset:
Член 14, параграф 2a (нов)
Article 14, paragraph 2 a (new)
Когато се извършва позоваване на настоящия параграф, се прилагат разпоредбите на член 5а, параграфи от 1 до 4 и член 7 от Решение 1999/468/ЕО, като се вземат предвид разпоредбите на член 8 от същото решение.
Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having due regard to the provisions of Article 8 thereof.
This amendment is needed in order to align the text to the provisions of the new comitology decision.
This amendment is needed in order to align the text to the provisions of the new comitology decision.
Environmental considerations
Environmental considerations
In accordance with the Cardiff process, environmental aspects must be integrated into all EU legislation.
In accordance with the Cardiff process, environmental aspects must be integrated into all EU legislation.
It is particularly relevant in this legislation since what a person eats does not stay in the human body but is dispersed into the natural environment and becomes part of the natural cycle.
It is particularly relevant in this legislation since what a person eats does not stay in the human body but is dispersed into the natural environment and becomes part of the natural cycle.
Negative environmental effects should therefore be taken into consideration when deciding to grant authorisation or not.
Negative environmental effects should therefore be taken into consideration when deciding to grant authorisation or not.
Article 175 of the Treaty establishing the European Communities should therefore also form the basis for the regulation.
Article 175 of the Treaty establishing the European Communities should therefore also form the basis for the regulation.
Transparency is a crucial factor if consumers are to feel confident in the EU's way of managing food-related issues.
Transparency is a crucial factor if consumers are to feel confident in the EU's way of managing food-related issues.
The Commission must, therefore, ensure the transparency of the authorisation procedure by making public all applications and making all relevant material in the matter available to the public.
The Commission must, therefore, ensure the transparency of the authorisation procedure by making public all applications and making all relevant material in the matter available to the public.
Producers applying for authorisation must always be informed directly on matters concerning their application.
Producers applying for authorisation must always be informed directly on matters concerning their application.
The Commission should be able, without difficulty, to explain the considerations on which its decision is based.
The Commission should be able, without difficulty, to explain the considerations on which its decision is based.
A transparent explanation of this nature would benefit consumers, industry and the Member States' authorities.
A transparent explanation of this nature would benefit consumers, industry and the Member States' authorities.
The Commission should, therefore, always make public its proposals for decisions, justify its proposal and explain the considerations on which its decision is based.
The Commission should, therefore, always make public its proposals for decisions, justify its proposal and explain the considerations on which its decision is based.
Where the adopted regulation departs from the Commission's original proposal to the Committee on the Food Chain and Animal Health, the Commission shall also explain the background to the final decision.
Where the adopted regulation departs from the Commission's original proposal to the Committee on the Food Chain and Animal Health, the Commission shall also explain the background to the final decision.
Food safety
Food safety
Given the resources at the EFSA's disposal and the quality standards required of the EFSA's opinion, six months, as the Commission has proposed, is not a reasonable period within which to produce an opinion on an application.
Given the resources at the EFSA's disposal and the quality standards required of the EFSA's opinion, six months, as the Commission has proposed, is not a reasonable period within which to produce an opinion on an application.
Having regard to food safety, therefore, it is proposed that this time period be extended so that the EFSA has nine months in which to present an opinion.
Having regard to food safety, therefore, it is proposed that this time period be extended so that the EFSA has nine months in which to present an opinion.
It is also important for certain groups of consumers that substances and uses which are no longer current are removed from the list.
It is also important for certain groups of consumers that substances and uses which are no longer current are removed from the list.
All authorisations for use of food additives, food enzymes and food flavourings must therefore be reviewed on a regular basis.
All authorisations for use of food additives, food enzymes and food flavourings must therefore be reviewed on a regular basis.
The new comitology procedure
The new comitology procedure
In the light of the new comitology procedure, a number of amendments are proposed to the Commission's proposal.
In the light of the new comitology procedure, a number of amendments are proposed to the Commission's proposal.
Mr Miroslav Ouzký
Mr Miroslav Ouzký
Subject: Opinion on the legal basis of the Proposal for a Regulation of the European Parliament and of the Council for a regulation on establishing a common authorisation procedure for food additives, food enzymes and food flavourings ( COM(2006)0423 ) – C6‑0258/2006 – 2006/0143(COD) )
Subject: Opinion on the legal basis of the Proposal for a Regulation of the European Parliament and of the Council for a regulation on establishing a common authorisation procedure for food additives, food enzymes and food flavourings ( COM(2006)0423 ) – C6‑0258/2006 – 2006/0143(COD) )
By letter of 28 February 2007 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.
By letter of 28 February 2007 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.
The lead committee's rapporteur, Ms Westlund, is proposing to change the legal basis of the proposal from Article 95 to Article 95 together with Article 175 of the EC Treaty.
The lead committee's rapporteur, Ms Westlund, is proposing to change the legal basis of the proposal from Article 95 to Article 95 together with Article 175 of the EC Treaty.
All Community acts must be founded upon a legal basis laid down in the Treaty (or in another legal act which they are intended to implement).
All Community acts must be founded upon a legal basis laid down in the Treaty (or in another legal act which they are intended to implement).
The legal basis defines the Community's competence ratione materiae and specifies how that competence is to be exercised, namely the legislative instrument(s) which may be used and the decision-making procedure.
The legal basis defines the Community's competence ratione materiae and specifies how that competence is to be exercised, namely the legislative instrument(s) which may be used and the decision-making procedure.
In view of the consequences of the legal basis, its choice is of basic importance, particularly for Parliament, since it determines what say, if any, Parliament has in the legislative process.
In view of the consequences of the legal basis, its choice is of basic importance, particularly for Parliament, since it determines what say, if any, Parliament has in the legislative process.
According to the Court of Justice the choice of legal basis is not a subjective one, but "must be based on objective factors which are amenable to judicial review"
According to the Court of Justice the choice of legal basis is not a subjective one, but "must be based on objective factors which are amenable to judicial review"
5. , such as the aim and content of the measure in question
5. , such as the aim and content of the measure in question
Furthermore, the decisive factor should be the main object of a measure.
Furthermore, the decisive factor should be the main object of a measure.
According to the case-law of the Court of Justice, a general Treaty article constitutes a sufficient legal basis even though the measure in question also seeks, in a subordinate manner, to attain an aim sought by a specific Treaty article
According to the case-law of the Court of Justice, a general Treaty article constitutes a sufficient legal basis even though the measure in question also seeks, in a subordinate manner, to attain an aim sought by a specific Treaty article
However, if the view were to be taken that the aims of protecting human health and the establishment and functioning of the internal market are indissolubly linked with each other without one being secondary and indirect in respect of the others, it might be considered that the two legal bases would have to be used, given that the same decision-making procedure (codecision) is provided for in both Articles 95 and 175(1)
However, if the view were to be taken that the aims of protecting human health and the establishment and functioning of the internal market are indissolubly linked with each other without one being secondary and indirect in respect of the others, it might be considered that the two legal bases would have to be used, given that the same decision-making procedure (codecision) is provided for in both Articles 95 and 175(1)
The lead committee proposes that Article 175
The lead committee proposes that Article 175
Article 175(1)
Article 175(1)
The Council, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee and the Committee of the Regions, shall decide what action is to be taken by the Community in order to achieve the objectives referred to in Article 174. together with Article 95
The Council, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee and the Committee of the Regions, shall decide what action is to be taken by the Community in order to achieve the objectives referred to in Article 174. together with Article 95
The Council
The Council
shall, acting in accordance with the procedure referred to in Article 251 and after consulting the
shall, acting in accordance with the procedure referred to in Article 251 and after consulting the
Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.
Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.
Within their respective powers, the
Within their respective powers, the
European Parliament and the Council will also seek to achieve this objective.
European Parliament and the Council will also seek to achieve this objective.
Moreover, without prejudice to paragraph 4, if, after the adoption by the Council or by the
Moreover, without prejudice to paragraph 4, if, after the adoption by the Council or by the
Commission of a harmonisation measure, a Member State deems it necessary to introduce national
Commission of a harmonisation measure, a Member State deems it necessary to introduce national
provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them.
provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them.
When justified by the complexity of the matter and in the absence of danger for human health, the
When justified by the complexity of the matter and in the absence of danger for human health, the
Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to six months.
Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to six months.
When, pursuant to paragraph 6, a Member State is authorised to maintain or introduce national
When, pursuant to paragraph 6, a Member State is authorised to maintain or introduce national
provisions derogating from a harmonisation measure, the Commission shall immediately examine
provisions derogating from a harmonisation measure, the Commission shall immediately examine
whether to propose an adaptation to that measure
whether to propose an adaptation to that measure
The harmonisation measures referred to above shall, in appropriate cases, include a safeguard
The harmonisation measures referred to above shall, in appropriate cases, include a safeguard
clause authorising the Member States to take, for one or more of the non-economic reasons referred to in Article 30, provisional measures subject to a Community control procedure. of the EC Treaty should be used as the legal basis for the proposal for a regulation.
clause authorising the Member States to take, for one or more of the non-economic reasons referred to in Article 30, provisional measures subject to a Community control procedure. of the EC Treaty should be used as the legal basis for the proposal for a regulation.
Article 175(1) refers to the objectives of Article 174
Article 175(1) refers to the objectives of Article 174
Article 174(1)
Article 174(1)
Community policy on the environment shall contribute to pursuit of the following objectives:
Community policy on the environment shall contribute to pursuit of the following objectives:
— preserving, protecting and improving the quality of the environment,
— preserving, protecting and improving the quality of the environment,
— protecting human health,
— protecting human health,
— prudent and rational utilisation of natural resources,
— prudent and rational utilisation of natural resources,
— promoting measures at international level to deal with regional or worldwide environmental problems. , in particular
— promoting measures at international level to deal with regional or worldwide environmental problems. , in particular
— promoting measures at international level to deal with regional or worldwide environmental problems.
— promoting measures at international level to deal with regional or worldwide environmental problems.
The aim and content of the proposal for Regulation and appraisal of its legal basis
The aim and content of the proposal for Regulation and appraisal of its legal basis
Article 1 provides as follows:
Article 1 provides as follows:
This Regulation lays down a common assessment and authorisation procedure (hereinafter referred to as the 'common procedure') for food additives, food enzymes, food flavourings and sources of food flavourings used or intended for use in or on foodstuffs (hereinafter referred to as the 'substances'), which contributes to the free movement of these substances within the Community.
This Regulation lays down a common assessment and authorisation procedure (hereinafter referred to as the 'common procedure') for food additives, food enzymes, food flavourings and sources of food flavourings used or intended for use in or on foodstuffs (hereinafter referred to as the 'substances'), which contributes to the free movement of these substances within the Community.
The common procedure shall set the procedural arrangements for updating the lists of substances the marketing of which is authorised in the Community pursuant to Regulation (EC) No XXX/2006, Regulation (EC) No YYY/2006 and Regulation (EC) No ZZZ/2006 (hereinafter referred to as the 'sectoral food laws').
The common procedure shall set the procedural arrangements for updating the lists of substances the marketing of which is authorised in the Community pursuant to Regulation (EC) No XXX/2006, Regulation (EC) No YYY/2006 and Regulation (EC) No ZZZ/2006 (hereinafter referred to as the 'sectoral food laws').
The criteria according to which substances can be included on the Community list provided for in Article 2, the content of the Regulation referred to in Article 7 and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law."
The criteria according to which substances can be included on the Community list provided for in Article 2, the content of the Regulation referred to in Article 7 and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law."
Recitals 1, 2 and 3 read as follows:
Recitals 1, 2 and 3 read as follows:
"(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens and to their social and economic interests.
"(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens and to their social and economic interests.
(2) A high level of protection of human life and health should be assured in the pursuit of Community policies.
(2) A high level of protection of human life and health should be assured in the pursuit of Community policies.
(3) So as to protect human health, the safety of additives, enzymes and flavourings for use in foodstuffs for human consumption must be assessed before they are placed on the Community market."
(3) So as to protect human health, the safety of additives, enzymes and flavourings for use in foodstuffs for human consumption must be assessed before they are placed on the Community market."
The content of the proposal for a regulation may be summarised as follows:
The content of the proposal for a regulation may be summarised as follows:
Chapter I: General principles
Chapter I: General principles
A common procedure is established for assessing and authorising additives, enzymes and flavourings.
A common procedure is established for assessing and authorising additives, enzymes and flavourings.
This procedure has been designed to be simple, fast and effective, while respecting the principles of good administration and legal certainty.
This procedure has been designed to be simple, fast and effective, while respecting the principles of good administration and legal certainty.
It is centred around the updating, on the basis of the criteria laid down in the sectoral laws, of a list of authorised substances that must be created and maintained by the Commission.
It is centred around the updating, on the basis of the criteria laid down in the sectoral laws, of a list of authorised substances that must be created and maintained by the Commission.
Chapter II: Common procedure
Chapter II: Common procedure
Under the proposed procedure, requests for updates must be addressed to the Commission, without first going through a national authority.
Under the proposed procedure, requests for updates must be addressed to the Commission, without first going through a national authority.
The Commission has to send the request file to the Authority and to the Member States and to seek the opinion of the Authority, which must issue such opinion within six months.
The Commission has to send the request file to the Authority and to the Member States and to seek the opinion of the Authority, which must issue such opinion within six months.
So as to ensure the binding effect of the updating measures, the proposal provides for their adoption to take the legal form of a regulation adopted in accordance with the comitology procedure.
So as to ensure the binding effect of the updating measures, the proposal provides for their adoption to take the legal form of a regulation adopted in accordance with the comitology procedure.
When the list is being updated within the framework of this proposal for a Regulation, any other relevant legitimate factors must be taken into account.
When the list is being updated within the framework of this proposal for a Regulation, any other relevant legitimate factors must be taken into account.
Thus, when initiating the decision-making process, the Commission, as risk manager, may propose a measure that is not in line with the outcome of the risk assessment carried out under the responsibility of the Authority.
Thus, when initiating the decision-making process, the Commission, as risk manager, may propose a measure that is not in line with the outcome of the risk assessment carried out under the responsibility of the Authority.
In such cases, the Commission must explain its reasons for such a departure.
In such cases, the Commission must explain its reasons for such a departure.
This is in line with the Codex Alimentarius General Principles on Risk Analysis.
This is in line with the Codex Alimentarius General Principles on Risk Analysis.
Chapter III: Miscellaneous provisions
Chapter III: Miscellaneous provisions
So as to take account of the specific characteristics of each sectoral food law, this proposal gives the Commission the power, following consultation of the Authority, to take decisions on various details of the procedure and provides for a certain degree of flexibility as regards complex and sensitive cases.
So as to take account of the specific characteristics of each sectoral food law, this proposal gives the Commission the power, following consultation of the Authority, to take decisions on various details of the procedure and provides for a certain degree of flexibility as regards complex and sensitive cases.
All non-confidential data should be made available to the public.
All non-confidential data should be made available to the public.
If the Member States or the Commission consider that a substance that has been authorised in accordance with this proposal poses serious risks to human health, animal health or the environment, emergency measures must be adopted.
If the Member States or the Commission consider that a substance that has been authorised in accordance with this proposal poses serious risks to human health, animal health or the environment, emergency measures must be adopted.
According to the explanatory memorandum "As part of the efforts undertaken to improve Community legislation on the basis of the 'farm to table' concept, in the White Paper on Food Safety, the Commission announced its intention to update and complete existing legislation with regard to additives and flavourings and to lay down specific provisions in respect of enzymes.
According to the explanatory memorandum "As part of the efforts undertaken to improve Community legislation on the basis of the 'farm to table' concept, in the White Paper on Food Safety, the Commission announced its intention to update and complete existing legislation with regard to additives and flavourings and to lay down specific provisions in respect of enzymes.
(Actions 11 and 13 of the White Paper).
(Actions 11 and 13 of the White Paper).
This proposal aims to ensure the proper functioning of the internal market, while also ensuring a high level of protection of human life and health as regards food additives, food enzymes and food flavourings.
This proposal aims to ensure the proper functioning of the internal market, while also ensuring a high level of protection of human life and health as regards food additives, food enzymes and food flavourings.