natgillin/translations-raw huggingface dataset:
shall, in verifying the application of Article 14 (2) (a), examine the information and data submitted by the applicant showing that the characteristics of the food are not different in comparison with the conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.
shall, in verifying the application of Article 14 (2) (a), examine the information and data submitted by the applicant showing that the characteristics of the food 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 or food containing or consisting of genetically modified organisms falling within the scope of this
In the case of genetically modified organisms or food containing or consisting of genetically modified organisms falling within the scope of this
environmental safety requirements laid down in Directive 2001/18/EC
environmental safety requirements laid down in Directive 2001/18/EC
shall apply to the evaluation
shall apply to the evaluation
to ensure that all appropriate measures are taken to prevent the adverse effects on human 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 health and the environment which might arise from the deliberate release of genetically modified organisms.
During evaluation of requests for the placing on the market of products
During evaluation of requests for the placing on the market of products
genetically modified organisms, the
genetically modified organisms, the
Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority in accordance with the provisions of that Directive.
Commission and the national and local authorities competent within the meaning of Directive 2001/18/EC shall be involved by the Authority in accordance with the provisions of that Directive.
In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:
In the event of an opinion in favour of authorising the food, the opinion shall also include the following particulars:
the name and address of the applicant;
the name and address of the applicant;
the designation of the food, and its specification;
the designation of the food, and its specification;
where appropriate, the information required under Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
where appropriate, the information required under Annex II of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;
the proposal for the labelling of the food and/or foods produced from it;
the proposal for the labelling of the food and/or foods produced from it;
where appropriate, any conditions or restrictions which should be imposed on the supply or use of the food and/or foods produced from it, 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 supply or use of the food and/or foods produced from it, including post-market monitoring requirements based on the outcome of the risk assessment
and effective measures to prevent the unintended presence of the food and/or foods produced from it in other products
and effective measures to prevent the unintended presence of the food and/or foods produced from it in other products
, validated by the reference laboratory,
, validated by the reference laboratory,
for detection, including sampling,
for detection, including sampling,
access to appropriate reference material,
access to appropriate reference material,
identification of
identification of
the sequence of
the sequence 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
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
or with it
or with it
where appropriate, the monitoring plan referred to in
where appropriate, the monitoring plan referred to in
information as to where the reference material or the samples of the applicant are to be made available to operators in the EU and for analytical purposes.
information as to where the reference material or the samples of the applicant are to be made available to operators in the EU and for analytical purposes.
The Authority shall forward its opinion to the Commission, the Member States
The Authority shall forward its opinion to the Commission, the Member States
, the appropriate national food safety, environmental risk and human and animal health risk assessment authorities or bodies
, the appropriate national food safety, environmental risk and human and animal health risk assessment authorities or bodies
and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion.
and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion.
The Authority shall
The Authority shall
also immediately
also immediately
its opinion
its opinion
, the assessment report and the grounds for the opinion
, the assessment report and the grounds for the opinion
The public may make comments to the Commission within
The public may make comments to the Commission within
three months
three months
from this publication.
from this publication.
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
Before the entry into application of this Regulation, the Commission shall publish a recommendation on the nature of the risk assessment to be undertaken by the Authority for the purpose of preparing its opinion.
Before the entry into application of this Regulation, the Commission shall publish a recommendation on the nature of the risk assessment to be undertaken by the Authority for the purpose of preparing its opinion.
Article 8 Authorisation by the Community
Article 8 Authorisation by the Community
Save in exceptionally complex cases, within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law and other legitimate factors relevant to the matter under consideration.
Save in exceptionally complex cases, within three months of receipt of the opinion of the Authority, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law and other legitimate factors relevant to the matter under consideration.
Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall
Where the draft decision is not in accordance with the opinion of the Authority, the Commission shall
reasons for
reasons for
taking a decision that differs from the Authority's opinion.
taking a decision that differs from the Authority's opinion.
The Commission's draft decision shall immediately be made public.
The Commission's draft decision shall immediately be made public.
In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 7
In the event of a draft decision which envisages the granting of authorisation, the draft decision shall include the particulars mentioned in Article 7
, the name of the authorisation-holder and, where appropriate, the unique code attributed to the genetically modified organism as referred to
, the name of the authorisation-holder and, where appropriate, the unique code attributed to the genetically modified organism as referred to
in Regulation
in Regulation
traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified
traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified
The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC.
The draft decision shall also include the opinions of the authorities required to be consulted in accordance with Directive 2001/18/EC.
A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36(2).
A final decision on the application shall be adopted in accordance with the procedure laid down in Article 36(2).
The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.
The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote.
The Commission shall without delay inform the applicant of the decision taken.
The Commission shall without delay inform the applicant of the decision taken.
It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies
It shall also, at the earliest opportunity, notify its decision to the European Parliament, the Member States and the appropriate food safety, environmental risk and human and animal health risk assessment authorities or bodies
The decision shall be published in the Official Journal of the European Communities.
The decision shall be published in the Official Journal of the European Communities.
Without prejudice to the procedure provided for in Article 11
Without prejudice to the procedure provided for in Article 11
, the authorisation granted in accordance with the procedure laid down in this Regulation
, the authorisation granted in accordance with the procedure laid down in this Regulation
the Community
the Community
, terminate after
, terminate after
ten years and shall be renewable in accordance with Article 12.
ten years and shall be renewable in accordance with Article 12.
The authorised food shall be entered in the Register referred to in Article 30.
The authorised food shall be entered in the Register referred to in Article 30.
Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2.
Each entry in the Register shall mention the date of authorisation and shall include the particulars referred to in paragraph 2.
It shall also indicate how and where the public can access the files relating to the application for authorisation, including the evaluation by the Authority, the opinions of the national bodies, the local authorities and public opinion, as well as the issues discussed in connection with the risk management decision and the result of the vote.
It shall also indicate how and where the public can access the files relating to the application for authorisation, including the evaluation by the Authority, the opinions of the national bodies, the local authorities and public opinion, as well as the issues discussed in connection with the risk management decision and the result of the vote.
The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used subject to their inclusion in a list of substances registered or authorised to the exclusion of others.
The authorisation under this Section shall be without prejudice to other provisions of Community law governing the use and placing on the market of substances which may only be used subject to their inclusion in a list of substances registered or authorised to the exclusion of others.
The granting of authorisation shall not diminish the general civil and criminal liability of any food operator in respect of the food concerned.
The granting of authorisation shall not diminish the general civil and criminal liability of any food operator in respect of the food concerned.
Article 9 Status of existing products
Article 9 Status of existing products
By derogation to Article 4 (2), a product falling within the scope of this Section which has been placed on the market under Directive 90/220/EEC before the entry into force of Regulation (EC) No 258/97 or in accordance with the provisions laid down in Regulation (EC) No 258/97 may continue to be placed on the market, used and processed provided that the following conditions are met:
By derogation to Article 4 (2), a product falling within the scope of this Section which has been placed on the market under Directive 90/220/EEC before the entry into force of Regulation (EC) No 258/97 or in accordance with the provisions laid down in Regulation (EC) No 258/97 may continue to be placed on the market, used and processed provided that the following conditions are met:
within six months of the entry into force of this Regulation, the person responsible for placing on the market the concerned product shall notify the Authority of the date at which it was first placed on the market in the Community.
within six months of the entry into force of this Regulation, the person responsible for placing on the market the concerned product shall notify the Authority of the date at which it was first placed on the market in the Community.
This notification shall be accompanied by the particulars mentioned in
This notification shall be accompanied by the particulars mentioned in
(3) and (5), as appropriate, which the Authority shall forward to the Commission and the Member States.
(3) and (5), as appropriate, which the Authority shall forward to the Commission and the Member States.
The Authority shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in
The Authority shall forward to the Community reference laboratory referred to in Article 33 the particulars referred to in
and shall ask it to test and validate the method of detection and identification proposed by the applicant;
and shall ask it to test and validate the method of detection and identification proposed by the applicant;
within one year of the entry into force of this Regulation, the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article.
within one year of the entry into force of this Regulation, the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article.
The product concerned shall be entered in the Register.
The product concerned shall be entered in the Register.
Each entry in the Register shall mention the date at which the concerned product was first placed on the market and shall include the particulars referred to in Article 8(2) as appropriate.
Each entry in the Register shall mention the date at which the concerned product was first placed on the market and shall include the particulars referred to in Article 8(2) as appropriate.
It shall also indicate how and where the public can access the files relating to the application and any information submitted subsequently, including the Authority's assessment and, where applicable, opinions of national bodies and of the public, as well as the issues discussed in connection with the risk management decision and the result of the vote
It shall also indicate how and where the public can access the files relating to the application and any information submitted subsequently, including the Authority's assessment and, where applicable, opinions of national bodies and of the public, as well as the issues discussed in connection with the risk management decision and the result of the vote
Within nine years from the date at which the concerned product was first placed on the market, the person responsible for placing it on the market shall submit an application in accordance with Article 12, which shall apply in a like manner.
Within nine years from the date at which the concerned product was first placed on the market, the person responsible for placing it on the market shall submit an application in accordance with Article 12, which shall apply in a like manner.
Products referred to in paragraph 1 and foods containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 10, 11 and 35, which shall apply in a like manner.
Products referred to in paragraph 1 and foods containing them or produced from them shall be subject to the provisions of this Regulation, in particular Articles 10, 11 and 35, which shall apply in a like manner.
Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 36(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the
Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the Commission, acting in accordance with the procedure laid down in Article 36(2), shall adopt a measure requiring the product concerned and any products derived from it to be withdrawn from the
Detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 36 (2).
Detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 36 (2).
Article 10 Supervision
Article 10 Supervision
After an authorisation has been issued in accordance with this Regulation,
After an authorisation has been issued in accordance with this Regulation,
all parties concerned
all parties concerned
shall comply with any conditions or restrictions which have been imposed in the authorisation.
shall comply with any conditions or restrictions which have been imposed in the authorisation.
Where post-market monitoring as referred to in
Where post-market monitoring as referred to in
(5)(b) has been imposed on the authorisation-holder, he shall ensure that it is carried out and shall submit reports to the Authority in accordance with the authorisation.
(5)(b) has been imposed on the authorisation-holder, he shall ensure that it is carried out and shall submit reports to the Authority in accordance with the authorisation.
The monitoring reports, excluding confidential information, shall be made accessible to the public.
The monitoring reports, excluding confidential information, shall be made accessible to the public.
If the authorisation-holder proposes to modify the terms of the authorisation, he shall submit an application to the Authority.
If the authorisation-holder proposes to modify the terms of the authorisation, he shall submit an application to the Authority.
The authorisation-holder shall forthwith inform the Authority of any new scientific or technical information which might influence the evaluation of the safety in use of the food.
The authorisation-holder shall forthwith inform the Authority of any new scientific or technical information which might influence the evaluation of the safety in use of the food.
In particular, the authorisation-holder shall forthwith inform the Authority of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market.
In particular, the authorisation-holder shall forthwith inform the Authority of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market.
The Authority shall examine the information forwarded and shall notify the Commission, the Member States and the local authorities.
The Authority shall examine the information forwarded and shall notify the Commission, the Member States and the local authorities.
The information forwarded shall be made accessible to the public.
The information forwarded shall be made accessible to the public.
Article 11 Modification, suspension and revocation of authorisations
Article 11 Modification, suspension and revocation of authorisations
Where, on its own initiative or following a request from a Member State or from the Commission, the Authority is of the opinion that an authorisation granted in accordance with this Regulation should be modified, suspended or revoked, it shall forthwith transmit this opinion to the Commission,
Where, on its own initiative or following a request from a Member State or from the Commission, the Authority is of the opinion that an authorisation granted in accordance with this Regulation should be modified, suspended or revoked, it shall forthwith transmit this opinion to the Commission,
the authorisation-holder, the Member States and the local authorities.
the authorisation-holder, the Member States and the local authorities.
The opinion shall be made accessible to the public
The opinion shall be made accessible to the public
The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken.
The Commission shall examine the opinion of the Authority as soon as possible and prepare a draft of the decision to be taken.
The draft shall be made accessible to the public.
The draft shall be made accessible to the public.
In the event of a draft decision which envisages the modification of the authorisation, the draft decision shall include any amendment needed to the particulars mentioned in Article 8 (2).
In the event of a draft decision which envisages the modification of the authorisation, the draft decision shall include any amendment needed to the particulars mentioned in Article 8 (2).
A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with the procedure laid down in Article 36 (2).
A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with the procedure laid down in Article 36 (2).
The Commission shall without delay inform the authorisation-holder of the decision taken.
The Commission shall without delay inform the authorisation-holder of the decision taken.
The Register shall be amended as appropriate.
The Register shall be amended as appropriate.
The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote
The public shall be given access to the issues discussed in connection with the risk management decision and the result of the vote
Article 12 Renewal of authorisations
Article 12 Renewal of authorisations
Without prejudice to the right of a third party to submit an application for authorisation for a food essentially similar to a food for which an authorisation has already been granted, authorisations under this Regulation shall be renewable for ten-
Without prejudice to the right of a third party to submit an application for authorisation for a food essentially similar to a food for which an authorisation has already been granted, authorisations under this Regulation shall be renewable for ten-
periods, on application to the Authority by the authorisation-holder at the latest one year before the expiry date of the authorisation.
periods, on application to the Authority by the authorisation-holder at the latest one year before the expiry date of the authorisation.