natgillin/translations-raw huggingface dataset:
period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if he can demonstrate that the food or feed for which he is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.
period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of another applicant if he can demonstrate that the food or feed for which he is seeking authorisation is essentially similar to a food or feed already authorised under this Regulation.
Article 33 Community reference laboratory
Article 33 Community reference laboratory
The Community reference laboratory and its duties and tasks shall be those laid down in the Annex.
The Community reference laboratory and its duties and tasks shall be those laid down in the Annex.
National reference laboratories may be established in accordance with the procedure laid down in Article 36 (2).
National reference laboratories may be established in accordance with the procedure laid down in Article 36 (2).
Detailed rules for implementing this Annex and any changes to it may be adopted in accordance with the procedure laid down in Article 36 (2).
Detailed rules for implementing this Annex and any changes to it may be adopted in accordance with the procedure laid down in Article 36 (2).
Article 34 Consultation with the European Group on Ethics in Science and New Technologies
Article 34 Consultation with the European Group on Ethics in Science and New Technologies
The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies established by
The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies established by
Commission Decision of 16 December 1997, with a view to obtaining its opinion on ethical issues.
Commission Decision of 16 December 1997, with a view to obtaining its opinion on ethical issues.
The Commission shall make available to the public the opinions of the European Group on Ethics in Science and New Technologies.
The Commission shall make available to the public the opinions of the European Group on Ethics in Science and New Technologies.
Article 35 Emergency measures
Article 35 Emergency measures
Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or feed authorised in accordance with this Regulation endangers human health, animal health or the environment, it
Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or feed authorised in accordance with this Regulation endangers human health, animal health or the environment, it
may provisionally restrict or prohibit the use and/or sale of the food or feed on its territory, as well as suspending or otherwise restricting the import thereto or export therefrom of the food or feed in question until a final decision is taken in accordance with Article 11 or Article 23, as appropriate.
may provisionally restrict or prohibit the use and/or sale of the food or feed on its territory, as well as suspending or otherwise restricting the import thereto or export therefrom of the food or feed in question until a final decision is taken in accordance with Article 11 or Article 23, as appropriate.
Member States shall ensure that, in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.
Member States shall ensure that, in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public.
The Member State shall immediately inform the Commission, the Authority and the other Member States of actions taken under this Article and give reasons for its decision and the new information or new assessment on which its decision is based, indicating whether and how the conditions of the consent should be amended or the consent should be terminated.
The Member State shall immediately inform the Commission, the Authority and the other Member States of actions taken under this Article and give reasons for its decision and the new information or new assessment on which its decision is based, indicating whether and how the conditions of the consent should be amended or the consent should be terminated.
A decision on this shall be taken within three months in accordance with the procedure laid down in Article 36(3).
A decision on this shall be taken within three months in accordance with the procedure laid down in Article 36(3).
Article 36 Implementing powers of the Commission
Article 36 Implementing powers of the Commission
(1) of Regulation (EC)
(1) of Regulation (EC)
No 178/2002
No 178/2002
When reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.
When reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.
The period provided for in Article 5 (6) of Decision 1999/468/EC shall be three months.
The period provided for in Article 5 (6) of Decision 1999/468/EC shall be three months.
When reference is made to this paragraph, the safeguard procedure laid down in Article 6 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.
When reference is made to this paragraph, the safeguard procedure laid down in Article 6 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.
Any Member State may refer the Commission's decision to the Council within 15 days from the receipt of the notification of this decision, in which case the Council, acting by a qualified majority, may take a different decision within one month from the date of referral to the Council.
Any Member State may refer the Commission's decision to the Council within 15 days from the receipt of the notification of this decision, in which case the Council, acting by a qualified majority, may take a different decision within one month from the date of referral to the Council.
Article 37 Repeals
Article 37 Repeals
The following Regulations are repealed with effect from the date of application of this Regulation:
The following Regulations are repealed with effect from the date of application of this Regulation:
Regulation (EC) No 1139/98;
Regulation (EC) No 1139/98;
Regulation (EC) No 49/2000;
Regulation (EC) No 49/2000;
Regulation (EC) No 50/2000.
Regulation (EC) No 50/2000.
Article 38 Amendments to Regulation (EC) No 258/97
Article 38 Amendments to Regulation (EC) No 258/97
Regulation (EC) No 258/97 is amended with effect from the date of application of this Regulation as follows:
Regulation (EC) No 258/97 is amended with effect from the date of application of this Regulation as follows:
The following provisions are deleted:
The following provisions are deleted:
Article 1 (2) (a) and (b),
Article 1 (2) (a) and (b),
Article 3 (2) second paragraph and (3),
Article 3 (2) second paragraph and (3),
Article 8 (1) (d),
Article 8 (1) (d),
Article 9,
Article 9,
In Article 3, the first sentence of paragraph 4 is replaced by the following:
In Article 3, the first sentence of paragraph 4 is replaced by the following:
"By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods or food ingredients referred to in Article 1 (2) (d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4 (3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained
"By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods or food ingredients referred to in Article 1 (2) (d) and (e) which, on the basis of the scientific evidence available and generally recognised or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4 (3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained
Amendments to Directive 82/471/EEC
Amendments to Directive 82/471/EEC
Directive 82/471/EEC is amended with effect from the date of application of this Regulation as follows:
Directive 82/471/EEC is amended with effect from the date of application of this Regulation as follows:
The following paragraph is added to Article 1:
The following paragraph is added to Article 1:
This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of
This Directive does not apply to products which act as direct or indirect protein sources that fall within the scope of
(EC) No .../2002 of
(EC) No .../2002 of
.... [on genetically modified food and feed]*.
.... [on genetically modified food and feed]*.
OJ L ..."
OJ L ..."
Article 40 Amendments to Directive 70/457/EEC
Article 40 Amendments to Directive 70/457/EEC
Directive 70/457/EEC is amended with effect from the date of application of this Regulation as follows:
Directive 70/457/EEC is amended with effect from the date of application of this Regulation as follows:
Article 4 (5) is replaced by the following:
Article 4 (5) is replaced by the following:
Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or feed falling within the scope of Article 16 of
Further, when material derived from a plant variety is intended to be used in food falling within the scope of Article 3, or feed falling within the scope of Article 16 of
(EC) No .../2002 of ...
(EC) No .../2002 of ...
[on genetically modified food and feed]*, the variety shall only be accepted if it has been approved in accordance with that Regulation.
[on genetically modified food and feed]*, the variety shall only be accepted if it has been approved in accordance with that Regulation.
* OJ L ..."
* OJ L ..."
Article 7 (4) is replaced by the following:
Article 7 (4) is replaced by the following:
"4. (a) In the case of a genetically modified variety as referred to in Article 4(4) an environmental risk assessment equivalent to that laid down in European Parliament and Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC* shall be carried out.
"4. (a) In the case of a genetically modified variety as referred to in Article 4(4) an environmental risk assessment equivalent to that laid down in European Parliament and Council Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC* shall be carried out.
Pending the entry into force of a European Parliament and Council Regulation, referred to in Article 12(3) of Directive 2001/18/EC, laying down the procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in Directive 2001/18/EC, genetically modified varieties shall only be accepted for inclusion in a national catalogue after having being accepted for placing on the market in accordance with Directive 2001/18/EC.
Pending the entry into force of a European Parliament and Council Regulation, referred to in Article 12(3) of Directive 2001/18/EC, laying down the procedures ensuring that the risk assessment, requirements regarding risk management, labelling, monitoring as appropriate, information to the public and safeguard clause are equivalent to those laid down in Directive 2001/18/EC, genetically modified varieties shall only be accepted for inclusion in a national catalogue after having being accepted for placing on the market in accordance with Directive 2001/18/EC.
Articles 13 to 24 of Directive 2001/18/EC shall no longer apply to genetically modified varieties once the Regulation referred to in subparagraph (b) and a sectoral Council Regulation regulating genetically modified plant varieties, introduced on a proposal from the Commission based on the appropriate legal basis in the Treaty, have entered into force.
Articles 13 to 24 of Directive 2001/18/EC shall no longer apply to genetically modified varieties once the Regulation referred to in subparagraph (b) and a sectoral Council Regulation regulating genetically modified plant varieties, introduced on a proposal from the Commission based on the appropriate legal basis in the Treaty, have entered into force.
The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure laid down in Article 40.
The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure laid down in Article 40.
Article 7 (5) is replaced by the following:
Article 7 (5) is replaced by the following:
Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of
Member States shall ensure that a variety intended to be used in food or feed as defined in Articles 2 and 3 of
No 178/2002 of 28 January 2002
No 178/2002 of 28 January 2002
Authority, and laying down procedures in matters of food safety*, is accepted only if it has been
Authority, and laying down procedures in matters of food safety*, is accepted only if it has been
authorised under the relevant legislation
authorised under the relevant legislation
Article 41 Amendments to Directive 70/458/EEC
Article 41 Amendments to Directive 70/458/EEC
Directive 70/458/EEC is amended with effect from the date of application of this Regulation as follows:
Directive 70/458/EEC is amended with effect from the date of application of this Regulation as follows:
Article 4 (3) is replaced by the following:
Article 4 (3) is replaced by the following:
Authority, and laying down procedures in matters of food safety*, is accepted only if it has been authorised pursuant to Regulation (EC) No 258/97 for food or Directive 90/220/EEC or Directive 2001/18/EC for feed or Regulation
Authority, and laying down procedures in matters of food safety*, is accepted only if it has been authorised pursuant to Regulation (EC) No 258/97 for food or Directive 90/220/EEC or Directive 2001/18/EC for feed or Regulation
[on genetically modified food and
[on genetically modified food and
Information to be provided in accordance with the Cartagena Protocol on Biosafety
Information to be provided in accordance with the Cartagena Protocol on Biosafety
Any authorisation
Any authorisation
renewal, modification, suspension or revocation of authorisation of a genetically modified organism, food or feed referred to in
renewal, modification, suspension or revocation of authorisation of a genetically modified organism, food or feed referred to in
16 (1) (b) shall be notified by the Commission to the Parties to the Cartagena Protocol on Biosafety through the Biosafety Clearing-House in accordance with Article 11 (1) or Article 12 (1),
16 (1) (b) shall be notified by the Commission to the Parties to the Cartagena Protocol on Biosafety through the Biosafety Clearing-House in accordance with Article 11 (1) or Article 12 (1),
as the case may be,
as the case may be,
of the Cartagena Protocol on
of the Cartagena Protocol on
The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the Biosafety Clearing-House.
The Commission shall provide a copy of the information, in writing, to the national focal point of each Party that informs the Secretariat in advance that it does not have access to the Biosafety Clearing-House.
The Commission shall also process requests for additional information made by any Party in accordance with Article 11 (3) and will provide copies of the laws, regulations and guidelines in accordance with Article 11 (5) of the Cartagena Protocol on Biosafety.
The Commission shall also process requests for additional information made by any Party in accordance with Article 11 (3) and will provide copies of the laws, regulations and guidelines in accordance with Article 11 (5) of the Cartagena Protocol on Biosafety.
States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
States shall notify those provisions to the Commission by [six months after the date of publication of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.
States shall notify those provisions to the Commission by [six months after the date of publication of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Transitional measures
Transitional measures
Requests submitted under Article 4 of Regulation (EC) No 258/97 before the entry into force of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6 (3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6 (3) or (4) of Regulation (EC) No 258/97.
Requests submitted under Article 4 of Regulation (EC) No 258/97 before the entry into force of this Regulation shall be transformed into applications under Chapter II, Section 1 of this Regulation where the initial assessment report provided for under Article 6 (3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6 (3) or (4) of Regulation (EC) No 258/97.
Applications which have been made concerning the placing on the market of GMOs pursuant to Directive 2001/18/EC or Regulation (EC) No 258/97, in relation to which the assessment procedure has not yet been completed on the date of entry into force of this Regulation, shall be subject to the following procedure:
Applications which have been made concerning the placing on the market of GMOs pursuant to Directive 2001/18/EC or Regulation (EC) No 258/97, in relation to which the assessment procedure has not yet been completed on the date of entry into force of this Regulation, shall be subject to the following procedure:
applicants shall supplement their applications within six months of the entry into force of this Regulation in the light of the requirements thereof and shall submit this information to the Authority;
applicants shall supplement their applications within six months of the entry into force of this Regulation in the light of the requirements thereof and shall submit this information to the Authority;
the Authority shall deliver an opinion pursuant to Article 7 and/or Article 19;
the Authority shall deliver an opinion pursuant to Article 7 and/or Article 19;
the Community authorisation shall be granted pursuant to Article 8 and/or Article 20.
the Community authorisation shall be granted pursuant to Article 8 and/or Article 20.
These products shall be subject to all other provisions of this Regulation.
These products shall be subject to all other provisions of this Regulation.
For a period of not more than 12 months following the date of application of this Regulation,
For a period of not more than 12 months following the date of application of this Regulation,
the labelling requirements laid down
the labelling requirements laid down
shall not apply to products which have been lawfully manufactured and labelled in the Community, or which have been lawfully imported into the Community and put into circulation, before the
shall not apply to products which have been lawfully manufactured and labelled in the Community, or which have been lawfully imported into the Community and put into circulation, before the
aforementioned date
aforementioned date
Notifications concerning products including use as feed submitted under Article 13 of Directive 2001/18/EC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for under Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.
Notifications concerning products including use as feed submitted under Article 13 of Directive 2001/18/EC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation where the assessment report provided for under Article 14 of Directive 2001/18/EC has not yet been sent to the Commission.
Requests submitted for products referred to in Article 16 (1) (c) under Article 7 of Directive 82/471/EEC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.
Requests submitted for products referred to in Article 16 (1) (c) under Article 7 of Directive 82/471/EEC before the entry into force of this Regulation shall be transformed into applications under Chapter III, Section 1 of this Regulation.
Requests submitted for products referred to in Article 16 (1) under Article 4 of Directive 70/524/EEC before the entry into force of this Regulation shall be complemented by applications under Chapter III, Section 1 of this Regulation.
Requests submitted for products referred to in Article 16 (1) under Article 4 of Directive 70/524/EEC before the entry into force of this Regulation shall be complemented by applications under Chapter III, Section 1 of this Regulation.
No later than two years from the date of entry into force of this Regulation and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation accompanied, where appropriate, by any suitable proposal.
No later than two years from the date of entry into force of this Regulation and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation accompanied, where appropriate, by any suitable proposal.
The report and any proposal shall be made accessible to the public.
The report and any proposal shall be made accessible to the public.
Notwithstanding the review provided for in paragraph 1, the Commission shall monitor the application of this Regulation and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.
Notwithstanding the review provided for in paragraph 1, the Commission shall monitor the application of this Regulation and its impact on human and animal health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.
Entry into force
Entry into force