natgillin/translations-raw huggingface dataset:
Provision should be made for consultation of the European Group on Ethics in Science and New Technologies established by Decision of 16 December 1997 with a view to obtaining advice on ethical issues regarding the placing on the market of genetically modified food or feed.
Provision should be made for consultation of the European Group on Ethics in Science and New Technologies established by Decision of 16 December 1997 with a view to obtaining advice on ethical issues regarding the placing on the market of genetically modified food or feed.
Such consultations should be without prejudice to the competence of Member States as regards ethical issues.
Such consultations should be without prejudice to the competence of Member States as regards ethical issues.
The content of this Regulation takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notification.
The content of this Regulation takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notification.
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the EU,
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the EU,
HAVE ADOPTED THIS REGULATION:
HAVE ADOPTED THIS REGULATION:
Chapter I
Chapter I
Objective and definitions Article 1 Objective
Objective and definitions Article 1 Objective
The objective of this Regulation
The objective of this Regulation
, in accordance with the precautionary principle,
, in accordance with the precautionary principle,
to provide the basis for the assurance of a high level of protection of human life and health, animal health and welfare, environment and consumers' interest in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market;
to provide the basis for the assurance of a high level of protection of human life and health, animal health and welfare, environment and consumers' interest in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market;
to lay down Community procedures for the authorisation and supervision of genetically modified food and feed;
to lay down Community procedures for the authorisation and supervision of genetically modified food and feed;
to lay down provisions for the labelling of genetically modified food and feed;
to lay down provisions for the labelling of genetically modified food and feed;
to prevent the unintended presence of material consisting of, containing or produced from GMOs in food and feed.
to prevent the unintended presence of material consisting of, containing or produced from GMOs in food and feed.
Article 2 Definitions
Article 2 Definitions
For the purposes of this Regulation:
For the purposes of this Regulation:
the definitions of "food', "feed', "placing on the market' and "traceability', laid down in Regulation (EC) No
the definitions of "food', "feed', "placing on the market' and "traceability', laid down in Regulation (EC) No
178/2002 shall
178/2002 shall
the definitions of "organism', "genetically modified organism' ("GMO'), "deliberate release' and "environmental risk assessment' laid down in Directive 2001/18/EC shall apply;
the definitions of "organism', "genetically modified organism' ("GMO'), "deliberate release' and "environmental risk assessment' laid down in Directive 2001/18/EC shall apply;
'genetically modified
'genetically modified
food' means food consisting
food' means food consisting
or produced from genetically modified organisms;
or produced from genetically modified organisms;
'genetically modified feed' means feed consisting of, containing or produced from genetically modified organisms;
'genetically modified feed' means feed consisting of, containing or produced from genetically modified organisms;
) 'genetically modified organisms for food use' means a genetically modified organism
) 'genetically modified organisms for food use' means a genetically modified organism
which may
which may
be used as food or as a source material for the production of food;
be used as food or as a source material for the production of food;
) 'genetically modified organisms for feed use' means a genetically modified organism
) 'genetically modified organisms for feed use' means a genetically modified organism
be used as feed or as a source material for the production of feed;
be used as feed or as a source material for the production of feed;
) "produced from genetically modified organisms' means derived, in whole or in part, from genetically modified organisms, but not
) "produced from genetically modified organisms' means derived, in whole or in part, from genetically modified organisms, but not
consisting of or containing
consisting of or containing
genetically modified organisms ;
genetically modified organisms ;
) 'control sample' means the genetically modified organism or its genetic material (positive sample)
) 'control sample' means the genetically modified organism or its genetic material (positive sample)
the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample);
the parental organism or its genetic material that has been used for the purpose of the genetic modification (negative sample);
'final consumer' means:
'final consumer' means:
as regards food, anyone who purchases a foodstuff for their personal or private consumption;
as regards food, anyone who purchases a foodstuff for their personal or private consumption;
as regards feed, a farmer who purchases, for the purpose of feeding animals intended in any way for human consumption, feed consisting of, containing or produced from genetically modified organisms.
as regards feed, a farmer who purchases, for the purpose of feeding animals intended in any way for human consumption, feed consisting of, containing or produced from genetically modified organisms.
Chapter II Genetically modified food
Chapter II Genetically modified food
Section 1
Section 1
Authorisation and Monitoring Article 3 Scope
Authorisation and Monitoring Article 3 Scope
This Section shall apply to:
This Section shall apply to:
genetically modified organisms for food use,
genetically modified organisms for food use,
genetically modified organisms,
genetically modified organisms,
food produced from or containing ingredients produced from genetically modified organisms.
food produced from or containing ingredients produced from genetically modified organisms.
Where necessary, it may be determined in accordance with the procedure laid down in Article 36(2)
Where necessary, it may be determined in accordance with the procedure laid down in Article 36(2)
that further types
that further types
of food
of food
within the scope of this Section.
within the scope of this Section.
Article 4 Requirements
Article 4 Requirements
Food falling within the scope of this Section must not:
Food falling within the scope of this Section must not:
present a
present a
danger to
danger to
human health or the environment,
human health or the environment,
mislead the consumer,
mislead the consumer,
differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.
differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.
No person shall place on the market a genetically modified organism for food use or food falling within the scope of this Section unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are adhered to.
No person shall place on the market a genetically modified organism for food use or food falling within the scope of this Section unless it is covered by an authorisation granted in accordance with this Section and the relevant conditions of the authorisation are adhered to.
No genetically modified organism for food use or food falling within the scope of this Section shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1.
No genetically modified organism for food use or food falling within the scope of this Section shall be authorised unless the applicant for such authorisation has adequately and sufficiently demonstrated that it satisfies the requirements of paragraph 1.
The authorisation referred to in paragraph 2 may cover:
The authorisation referred to in paragraph 2 may cover:
a genetically modified organism and foods
a genetically modified organism and foods
that genetically modified organism as well as foods produced from or containing ingredients produced from that genetically modified organism, or
that genetically modified organism as well as foods produced from or containing ingredients produced from that genetically modified organism, or
a food produced from or containing an ingredient produced from a genetically modified organism as well as foods produced from or containing that food.
a food produced from or containing an ingredient produced from a genetically modified organism as well as foods produced from or containing that food.
An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.
An authorisation as referred to in paragraph 2 shall not be granted, refused, renewed, modified, suspended or revoked except on the grounds and under the procedures set out in this Regulation.
The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder, shall be established in the Community.
The applicant for an authorisation as referred to in paragraph 2 and, after the authorisation is granted, the authorisation-holder, shall be established in the Community.
Authorisation under this Regulation is without prejudice to
Authorisation under this Regulation is without prejudice to
Directive 70/457/EEC
Directive 70/457/EEC
of 29 September 1970 on the common catalogue of varieties of agricultural plant species
of 29 September 1970 on the common catalogue of varieties of agricultural plant species
Directive 70/458/EEC
Directive 70/458/EEC
of 29 September 1970 on the marketing of vegetable
of 29 September 1970 on the marketing of vegetable
Application for authorisation
Application for authorisation
To obtain the authorisation referred to in Article 4 (2), an application shall be submitted to the European Food
To obtain the authorisation referred to in Article 4 (2), an application shall be submitted to the European Food
Authority, hereinafter referred to as "the Authority'.
Authority, hereinafter referred to as "the Authority'.
The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15
The Authority shall acknowledge receipt of the application, in writing, to the applicant within 15
days of its receipt.
days of its receipt.
The acknowledgement shall state the date of receipt of the application.
The acknowledgement shall state the date of receipt of the application.
The application shall be accompanied by the following particulars and documents:
The application shall be accompanied by the following particulars and documents:
the name and the address of the applicant;
the name and the address of the applicant;
the designation of the food, and its specification, including the transformation event(s) used;
the designation of the food, and its specification, including the transformation event(s) used;
where appropriate, the information for the purpose of complying with Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
where appropriate, the information for the purpose of complying with Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
where appropriate, a detailed description of the method of production and manufacturing;
where appropriate, a detailed description of the method of production and manufacturing;
a copy of the studies,
a copy of the studies,
including independent, peer-reviewed studies,
including independent, peer-reviewed studies,
which have been carried out and any other material which is available to demonstrate that the food complies with the criteria laid down in Article 4(1);
which have been carried out and any other material which is available to demonstrate that the food complies with the criteria laid down in Article 4(1);
either an analysis, supported by appropriate information and data, demonstrating that the food is not different to a conventional food, having regard to the criteria specified in Article 14(2)(a), or a proposal for labelling the food in accordance with Article 14(2)(a) and (3);
either an analysis, supported by appropriate information and data, demonstrating that the food is not different to a conventional food, having regard to the criteria specified in Article 14(2)(a), or a proposal for labelling the food in accordance with Article 14(2)(a) and (3);
either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 14(2)(b);
either a reasoned statement that the food does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with Article 14(2)(b);
a proposal for the labelling of the food and/or foods produced from it in accordance with Article 14(1);
a proposal for the labelling of the food and/or foods produced from it in accordance with Article 14(1);
) where appropriate, the conditions for placing on the market the food or foods produced from it , including specific conditions for use and handling;
) where appropriate, the conditions for placing on the market the food or foods produced from it , including specific conditions for use and handling;
) a method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it;
) a method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it;
) samples of the food and their control samples;
) samples of the food and their control samples;
information on the place where the reference material or the samples of the applicant are to be made available to authorities and operators in the EU;
information on the place where the reference material or the samples of the applicant are to be made available to authorities and operators in the EU;
) where appropriate, a proposal for post-market monitoring for the use of the food for human consumption;
) where appropriate, a proposal for post-market monitoring for the use of the food for human consumption;
) a summary of the dossier
) a summary of the dossier
in a standardised form
in a standardised form
In the case of an application relating to a GMO for food use, references to "food" in paragraph 3 shall be interpreted as referring to food
In the case of an application relating to a GMO for food use, references to "food" in paragraph 3 shall be interpreted as referring to food
or produced from the GMO in respect of which an application is made.
or produced from the GMO in respect of which an application is made.
application shall also be accompanied by:
application shall also be accompanied by:
the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC
the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC
and a copy of the decision authorising
and a copy of the decision authorising
the placing on the market of the genetically modified organism under part C of Directive
the placing on the market of the genetically modified organism under part C of Directive
a monitoring plan for environmental effects according to Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the
a monitoring plan for environmental effects according to Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the
the application concerns a substance the use and placing on the market of which is subject under other provisions of Community law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.
the application concerns a substance the use and placing on the market of which is subject under other provisions of Community law to its inclusion on a list of substances registered or authorised to the exclusion of others, this must be stated in the application and the status of the substance under the relevant legislation must be indicated.
The Commission, having first consulted the Authority
The Commission, having first consulted the Authority
and the national and local authorities competent within the meaning of Directive 2001/18/EC
and the national and local authorities competent within the meaning of Directive 2001/18/EC
establish, in accordance with the procedure laid down in Article 36(2), implementing rules for the application of this Article.
establish, in accordance with the procedure laid down in Article 36(2), implementing rules for the application of this Article.
Before the entry into force of this Regulation,
Before the entry into force of this Regulation,
the Authority shall publish detailed guidance concerning the preparation and the presentation of the application.
the Authority shall publish detailed guidance concerning the preparation and the presentation of the application.
Guides to good segregation practice for food and food ingredients
Guides to good segregation practice for food and food ingredients
The Member States shall encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination of food by genetically modified material.
The Member States shall encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination of food by genetically modified material.
Article 7 Opinion of the Authority
Article 7 Opinion of the Authority
Save in exceptionally complex cases, the Authority shall give an opinion within
Save in exceptionally complex cases, the Authority shall give an opinion within
months of the receipt of a valid application.
months of the receipt of a valid application.
The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.
The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specific time limit.
Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided.
Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended until such time that this information has been provided.
Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.
Likewise, this time limit shall be suspended for the time allowed to the applicant to prepare oral or written explanations.
The Authority shall forward the application within 15 days of its receipt to the competent authority or authorities of the Member States.
The Authority shall forward the application within 15 days of its receipt to the competent authority or authorities of the Member States.
The competent authorities, designated by the Member States, shall forward comments or reasoned objections within four months of the receipt of the application to the Authority which shall immediately circulate them to all competent authorities.
The competent authorities, designated by the Member States, shall forward comments or reasoned objections within four months of the receipt of the application to the Authority which shall immediately circulate them to all competent authorities.
Where the Authority's opinion is not in accordance with the opinion of a competent authority of a Member State, the Authority's opinion shall provide an explanation of the reasons for the differences.
Where the Authority's opinion is not in accordance with the opinion of a competent authority of a Member State, the Authority's opinion shall provide an explanation of the reasons for the differences.
In order to prepare its opinion, the Authority:
In order to prepare its opinion, the Authority:
shall verify that the particulars and documents submitted by the applicant are in accordance with
shall verify that the particulars and documents submitted by the applicant are in accordance with
, and examine whether the food complies with the criteria laid down in Article 4 (1);
, and examine whether the food complies with the criteria laid down in Article 4 (1);
shall make the application and any supplementary information supplied by the applicant available to the Member States and to the Commission;
shall make the application and any supplementary information supplied by the applicant available to the Member States and to the Commission;
shall make the summary of the dossier mentioned in
shall make the summary of the dossier mentioned in
available to the public;
available to the public;
it shall also be ensured that, on request, the public has reasonable access to the entire application, excluding confidential information.
it shall also be ensured that, on request, the public has reasonable access to the entire application, excluding confidential information.
An appropriate reference shall be made in connection with publication of the summary;
An appropriate reference shall be made in connection with publication of the summary;
may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food;
may ask the appropriate food assessment body of a Member State to carry out a safety assessment of the food;
take account of the results of the environmental risk assessment under
take account of the results of the environmental risk assessment under
shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in
shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in
The reference laboratory shall
The reference laboratory shall
test and validate the method of detection and identification proposed by the applicant
test and validate the method of detection and identification proposed by the applicant
and shall subsequently publish that method
and shall subsequently publish that method