natgillin/translations-raw huggingface dataset:
The Authority shall acknowledge receipt of the application, in writing, to the authorisation-holder within 15 days of its receipt.
The Authority shall acknowledge receipt of the application, in writing, to the authorisation-holder within 15 days of its receipt.
a copy of the authorisation for placing the food on the market;
a copy of the authorisation for placing the food on the market;
a report on the results of the
a report on the results of the
of the use of food for human consumption
of the use of food for human consumption
, if so specified in the authorisation
, if so specified in the authorisation
in accordance with Article 5(3)(m)
in accordance with Article 5(3)(m)
without prejudice to the obligations laid down in Article 10(3),
without prejudice to the obligations laid down in Article 10(3),
any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;
any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;
where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.
where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.
Article 7 and Article 8 shall apply in a like manner.
Article 7 and Article 8 shall apply in a like manner.
Where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date,
Where, for reasons beyond the control of the authorisation-holder, no decision is taken on the renewal of an authorisation before its expiry date,
the authorisation
the authorisation
of the product shall automatically be extended
of the product shall automatically be extended
once by one year or
once by one year or
until the Commission takes a decision
until the Commission takes a decision
within that year
within that year
The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority, in accordance with the procedure laid down in Article 36 (2).
The implementing rules for the application of this Article shall be established by the Commission after consulting the Authority, in accordance with the procedure laid down in Article 36 (2).
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.
Section 2
Section 2
Labelling Article 13 Scope
Labelling Article 13 Scope
This Section shall apply to foods which are to be delivered as such to the final consumer or mass caterers in the Community and which:
This Section shall apply to foods which are to be delivered as such to the final consumer or mass caterers in the Community and which:
genetically modified organisms, or
genetically modified organisms, or
are produced from or contain ingredients produced from genetically modified organisms.
are produced from or contain ingredients produced from genetically modified organisms.
This Section shall not apply to processing aids.
This Section shall not apply to processing aids.
This Section shall not apply to foods produced from animals fed with GMOs or products thereof.
This Section shall not apply to foods produced from animals fed with GMOs or products thereof.
This Section shall not apply to foods containing
This Section shall not apply to foods containing
material produced
material produced
from genetically modified organisms in a proportion no higher than
from genetically modified organisms in a proportion no higher than
0,5% or a lower threshold
0,5% or a lower threshold
established in accordance with the procedure laid down in Article 36(2), provided that this presence is adventitious or technically unavoidable.
established in accordance with the procedure laid down in Article 36(2), provided that this presence is adventitious or technically unavoidable.
As and when advances in science and technology allow, appropriately lower thresholds shall be established.
As and when advances in science and technology allow, appropriately lower thresholds shall be established.
In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified
In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified
The Commission shall draw up a list of criteria for determining these "appropriate steps".
The Commission shall draw up a list of criteria for determining these "appropriate steps".
In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.
In cooperation with the Authority, the Member States and the local authorities, the Commission shall also lay down appropriate measures to ensure that the utmost care is taken to avoid contamination.
Article 14 Requirements
Article 14 Requirements
Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following
Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following
specific labelling requirements:
specific labelling requirements:
Where the food consists of more than one ingredient, the words "genetically modified" or "produced from genetically modified [name of
Where the food consists of more than one ingredient, the words "genetically modified" or "produced from genetically modified [name of
appear in the list of ingredients provided for in Article 6 of Directive 2000/13/EC in parentheses immediately following the ingredient concerned.
appear in the list of ingredients provided for in Article 6 of Directive 2000/13/EC in parentheses immediately following the ingredient concerned.
Alternatively, these words may appear in a footnote to the list of ingredients.
Alternatively, these words may appear in a footnote to the list of ingredients.
It shall be printed in a font of at least the same size as the list of ingredients.
It shall be printed in a font of at least the same size as the list of ingredients.
Where the ingredient is designated by the name of a category, the words "contains [name of ingredient] produced from genetically modified [name of
Where the ingredient is designated by the name of a category, the words "contains [name of ingredient] produced from genetically modified [name of
appear in the list of ingredients.
appear in the list of ingredients.
Where there is no list of ingredients, the words "genetically modified" or "produced from genetically modified (name of
Where there is no list of ingredients, the words "genetically modified" or "produced from genetically modified (name of
appear clearly on the labelling.
appear clearly on the labelling.
Where the food is offered for sale to the
Where the food is offered for sale to the
consumer or to mass caterers without pre-packaging,
consumer or to mass caterers without pre-packaging,
or in small pre-packaged units,
or in small pre-packaged units,
the information required under this paragraph must be
the information required under this paragraph must be
permanently and visibly
permanently and visibly
the food display or right next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.
the food display or right next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.
In addition to the labelling requirements laid down in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases:
In addition to the labelling requirements laid down in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases:
Where a food is not equivalent to its conventional counterpart as regards
Where a food is not equivalent to its conventional counterpart as regards
these characteristics or properties
these characteristics or properties
nutritional value or nutritional effects,
nutritional value or nutritional effects,
intended use of the food,
intended use of the food,
implications for the health of certain sections of the population.
implications for the health of certain sections of the population.
Where a food may give rise to ethical or religious concerns.
Where a food may give rise to ethical or religious concerns.
In addition to the labelling requirements laid down in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.
In addition to the labelling requirements laid down in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.
Article 15 Implementing measures
Article 15 Implementing measures
Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).
Detailed rules for implementing this Section may be adopted in accordance with the procedure laid down in Article 36 (2).
Chapter III Genetically modified feed
Chapter III Genetically modified feed
Authorisation and Monitoring Article 16 Scope
Authorisation and Monitoring Article 16 Scope
genetically modified organisms for feed use;
genetically modified organisms for feed use;
genetically modified organisms;
genetically modified organisms;
feed produced from genetically modified organisms.
feed produced from genetically modified organisms.
of feed
of feed
Article 17 Requirements
Article 17 Requirements
Feed referred to in Article 16 (1) must not:
Feed referred to in Article 16 (1) must not:
present a risk for animal health, human health or the environment;
present a risk for animal health, human health or the environment;
mislead the user;
mislead the user;
harm the consumer by impairing the distinctive features of the animal products;
harm the consumer by impairing the distinctive features of the animal products;
differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.
differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.
No person shall place on the market, use or process a product referred to in Article 16 (1) for feed use or feed 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, use or process a product referred to in Article 16 (1) for feed use or feed 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 product referred to in Article 16(1) for feed use or feed 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 product referred to in Article 16(1) for feed use or feed 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.
consisting of or
consisting of or
containing genetically
containing genetically
as well as feed produced from
as well as feed produced from
genetically modified
genetically modified
a feed produced from a genetically modified organism as well as feed produced from or containing that feed.
a feed produced from a genetically modified organism as well as feed produced from or containing that feed.
7 Authorisation under this Regulation is without prejudice to Directive 70/457/EEC and Directive
7 Authorisation under this Regulation is without prejudice to Directive 70/457/EEC and Directive
To obtain the authorisation referred to in Article 17 (2), an application shall be submitted to the Authority.
To obtain the authorisation referred to in Article 17 (2), an application shall be submitted to the Authority.
The application shall be accompanied by the following:
The application shall be accompanied by the following:
the designation of the feed referred to in Article 16 (1), and its specification, including the transformation event(s) used;
the designation of the feed referred to in Article 16 (1), and its specification, including the transformation event(s) used;
where appropriate, a detailed description of the method of production, manufacturing and intended uses of the feed referred to in Article 16 (1);
where appropriate, a detailed description of the method of production, manufacturing and intended uses of the feed referred to in Article 16 (1);
which have been carried out and any other material which is available to demonstrate that the feed referred to in Article 16(1) complies with the criteria laid down in Article 17(1), and in particular for feed falling within the scope of Directive 82/471/EEC, the information required under
which have been carried out and any other material which is available to demonstrate that the feed referred to in Article 16(1) complies with the criteria laid down in Article 17(1), and in particular for feed falling within the scope of Directive 82/471/EEC, the information required under
Directive 83/228/EEC
Directive 83/228/EEC
of 18 April 1983
of 18 April 1983
on the fixing of guidelines for the assessment of certain products used in animal nutrition
on the fixing of guidelines for the assessment of certain products used in animal nutrition
proposal for labelling the feed referred to in Article 16(1)
proposal for labelling the feed referred to in Article 16(1)
consisting of, containing or produced from genetically modified organisms
consisting of, containing or produced from genetically modified organisms
in accordance with
in accordance with
either a reasoned statement that the feed referred to in Article 16 (1) does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with
either a reasoned statement that the feed referred to in Article 16 (1) does not give rise to ethical or religious concerns, or a proposal for labelling it in accordance with
where appropriate, the conditions for placing the feed referred to in Article 16 (1) on the market, including specific conditions for use and handling;
where appropriate, the conditions for placing the feed referred to in Article 16 (1) on the market, 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 feed referred to in Article 16 (1);
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 feed referred to in Article 16 (1);
samples of the feed referred to in Article 16 (1) and their control samples;
samples of the feed referred to in Article 16 (1) and their control samples;
) where appropriate, a proposal for post-market monitoring for the use of the feed referred to in Article 16 (1) for animal consumption;
) where appropriate, a proposal for post-market monitoring for the use of the feed referred to in Article 16 (1) for animal consumption;
In the case of an application relating to a GMO for feed use, references to "feed" in paragraph 3 shall be interpreted as referring to feed
In the case of an application relating to a GMO for feed use, references to "feed" in paragraph 3 shall be interpreted as referring to feed
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
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 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 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.
and the national and local authorities competent within the meaning of Directive 2001/18/EC, shall
and the national and local authorities competent within the meaning of Directive 2001/18/EC, shall
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.
Opinion of the Authority
Opinion of the Authority
Save in exceptionally complex cases, the Authority shall give an opinion within 6 months of the receipt of a valid application.
Save in exceptionally complex cases, the Authority shall give an opinion within 6 months of the receipt of a valid application.
, and examine whether the feed referred to in Article 16 (1) complies with the criteria laid down in Article 17 (1);
, and examine whether the feed referred to in Article 16 (1) complies with the criteria laid down in Article 17 (1);
ask the appropriate feed assessment body of
ask the appropriate feed assessment body of
in which the person applying for authorisation is established
in which the person applying for authorisation is established
to carry out a safety assessment of the feed referred to in Article 16(1)
to carry out a safety assessment of the feed referred to in Article 16(1)
, and shall take due account of the findings of the assessment
, and shall take due account of the findings of the assessment
shall take account of the results of the environmental risk assessment under
shall take account of the results of the environmental risk assessment under
shall, in verifying the application of
shall, in verifying the application of
(3) (c), examine the information and data submitted by the applicant showing that the characteristics of the feed referred to in Article 16 (1) are not different in comparison with the conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
(3) (c), examine the information and data submitted by the applicant showing that the characteristics of the feed referred to in Article 16 (1) are not different in comparison with the conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
In the case of genetically modified organisms and feed referred to respectively in Article 16(1)(a) and
In the case of genetically modified organisms and feed referred to respectively in Article 16(1)(a) and
to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of genetically modified organisms.
to ensure that all appropriate measures are taken to prevent the adverse effects on human and animal health and the environment which might arise from the deliberate release of genetically modified organisms.
Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority
Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority
the provisions of that Directive
the provisions of that Directive
In the event of an opinion in favour of authorising the feed referred to in Article 16 (1), the opinion shall also include the following particulars:
In the event of an opinion in favour of authorising the feed referred to in Article 16 (1), the opinion shall also include the following particulars:
the designation of the feed referred to in Article 16 (1), and its specification;
the designation of the feed referred to in Article 16 (1), and its specification;
the proposal for the labelling of the feed referred to in Article 16 (1);
the proposal for the labelling of the feed referred to in Article 16 (1);
where appropriate, any conditions or restrictions which should be imposed on the placing on the market, including specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment
where appropriate, any conditions or restrictions which should be imposed on the placing on the market, including specific conditions or restrictions for use and handling, including post-market monitoring requirements based on the outcome of the risk assessment
and effective measures to prevent the unintended presence of the feed or feed produced from it in other feed products
and effective measures to prevent the unintended presence of the feed or feed produced from it in other feed products
for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed referred to in Article 16(l);
for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the feed referred to in Article 16(l);
where appropriate, the monitoring plan as referred to in
where appropriate, the monitoring plan as referred to in
information on the place where the reference material or the samples of the applicant are to be made available to operators in the EU.
information on the place where the reference material or the samples of the applicant are to be made available to operators in the EU.
and the applicant, including a report describing its assessment of the feed referred to in Article 16(1) and stating the reasons for its opinion.
and the applicant, including a report describing its assessment of the feed referred to in Article 16(1) and stating the reasons for its opinion.
Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information.
Reference shall be made to the possibility for the public to have access to the entire application, excluding confidential information.
Authorisation by the Community
Authorisation by the Community
In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in
In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in
Article 19 (6)
Article 19 (6)