natgillin/translations-raw huggingface dataset:
, 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
Without prejudice to the procedure provided for in Article 23,
Without prejudice to the procedure provided for in Article 23,
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
ten years and shall be renewable in accordance with
ten years and shall be renewable in accordance with
The authorised feed shall be entered in the Register referred to in Article 30.
The authorised feed shall be entered in the Register referred to in Article 30.
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 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 authorised to the exclusion of others.
The granting of authorisation shall not diminish the general civil and criminal liability of any feed operator in respect of the feed concerned.
The granting of authorisation shall not diminish the general civil and criminal liability of any feed operator in respect of the feed concerned.
Status of existing products
Status of existing products
By derogation to Article 17 (2), products as referred to in Article 16 (1) which have been authorised before the date of application of this Regulation
By derogation to Article 17 (2), products as referred to in Article 16 (1) which have been authorised before the date of application of this Regulation
under Directives 90/220/EEC or 2001/18/EC, including use as feed,
under Directives 90/220/EEC or 2001/18/EC, including use as feed,
under Directive 82/471/EEC, which are produced from GMOs, or
under Directive 82/471/EEC, which are produced from GMOs, or
under Directive 70/524/EEC which
under Directive 70/524/EEC which
or are produced from GMOs,
or are produced from GMOs,
may continue to be placed on the market, used and processed provided that the following conditions are met:
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 products shall notify the Authority of the date at which they were 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 products shall notify the Authority of the date at which they were first placed on the market in the Community.
(3) (i) and (j) and shall ask it to test and validate the method of detection and identification proposed by the applicant;
(3) (i) and (j) and shall ask it to test and validate the method of detection and identification proposed by the applicant;
The products concerned shall be entered in the Register.
The products concerned shall be entered in the Register.
Each entry in the Register shall mention the date at which the concerned products were first placed on the market and shall include the particulars referred to in
Each entry in the Register shall mention the date at which the concerned products were first placed on the market and shall include the particulars referred to in
(2) as appropriate.
(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 products were first placed on the market, the person responsible for placing them on the market shall submit an application in accordance with
Within nine years from the date at which the concerned products were first placed on the market, the person responsible for placing them on the market shall submit an application in accordance with
, which shall apply in a like manner.
, which shall apply in a like manner.
Products referred to in paragraph 1 and feed containing them or produced from them shall be subject to the provisions of this Regulation, in particular
Products referred to in paragraph 1 and feed containing them or produced from them shall be subject to the provisions of this Regulation, in particular
Articles 22, 23
Articles 22, 23
and 35, which shall apply in a like manner.
and 35, which shall apply in a like manner.
case of authorisations not issued to a specific holder, the person who imports, produces or manufactures the products referred to in this Article shall submit the information or the application to the Authority.
case of authorisations not issued to a specific holder, the person who imports, produces or manufactures the products referred to in this Article shall submit the information or the 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 feed referred to in Article 16(1).
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 feed referred to in Article 16(1).
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 feed referred to in Article 16(1) 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 feed referred to in Article 16(1) is placed on the market.
The Authority shall examine the information forwarded and inform the Commission, the Member States and the local authorities.
The Authority shall examine the information forwarded and inform 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
Modification, suspension and revocation of authorisations
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 authorisation-holder
the Member States and the local authorities.
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.
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
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
A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with Article 36 (2).
A final decision on the modification, the suspension or the revocation of the authorisation shall be adopted in accordance with Article 36 (2).
The decision
The decision
shall be published in the Official Journal of the European Communities.
shall be published in the Official Journal of the European Communities.
Renewal of authorisations
Renewal of authorisations
Without prejudice to the right of a third party to submit an application for authorisation for a feed essentially similar to a feed 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 feed essentially similar to a feed for which an authorisation has already been granted, authorisations under this Regulation shall be renewable for ten-
a copy of the authorisation for placing the feed on the market;
a copy of the authorisation for placing the feed on the market;
a report on the results of the monitoring, if so specified in the authorisation;
a report on the results of the monitoring, if so specified in the authorisation;
any other new information which has become available with regard to the evaluation of the safety in use of the feed and the risks of the feed to animals, humans or the environment;
any other new information which has become available with regard to the evaluation of the safety in use of the feed and the risks of the feed to animals, humans or the environment;
shall apply in a like manner.
shall apply in a like manner.
within that year.
within that year.
Labelling Article
Labelling Article
This Section shall apply to feed referred to in Article 16 (1).
This Section shall apply to feed referred to in Article 16 (1).
This Section shall not apply to feed containing
This Section shall not apply to feed containing
produced from genetically modified organisms in a proportion no higher than
produced from genetically modified organisms in a proportion no higher than
In order to establish that the presence of this
In order to establish that the presence of this
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
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
Without prejudice to the other requirements of Community law concerning the labelling of feed, feed referred to in Article 16 (1) shall be subject to
Without prejudice to the other requirements of Community law concerning the labelling of feed, feed referred to in Article 16 (1) shall be subject to
additional specific labelling requirements laid down in this Article.
additional specific labelling requirements laid down in this Article.
By way of derogation
By way of derogation
from paragraph 1
from paragraph 1
the exemptions
the exemptions
labelling requirements provided for in Article 6 (3)
labelling requirements provided for in Article 6 (3)
of Council
of Council
Directive 96/25/EC
Directive 96/25/EC
of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC
of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC
shall not be applicable for feed referred to in Article 16 (1).
shall not be applicable for feed referred to in Article 16 (1).
No person shall place a feed referred to in Article 16(1) on the market unless he ensures that the particulars specified below are shown, in a clearly visible, legible and indelible manner,
No person shall place a feed referred to in Article 16(1) on the market unless he ensures that the particulars specified below are shown, in a clearly visible, legible and indelible manner,
on the packaging, the container, a label or an accompanying document
on the packaging, the container, a label or an accompanying document
the name of the feed:
the name of the feed:
for genetically modified feed the name shall be: "genetically modified [name of the feed]";
for genetically modified feed the name shall be: "genetically modified [name of the feed]";
for feed produced from genetically modified organisms: "produced from genetically modified [name of the feed from which the feed is
for feed produced from genetically modified organisms: "produced from genetically modified [name of the feed from which the feed is
for feed referred to in Article 16(1)(b) the name of the feed
for feed referred to in Article 16(1)(b) the name of the feed
shall be accompanied by the relevant unique code as established in Regulation (EC)
shall be accompanied by the relevant unique code as established in Regulation (EC)
as specified in the authorisation, any characteristic of the feed referred to in Article 16 (1) such as those indicated hereunder, which is not equivalent to its conventional counterpart:
as specified in the authorisation, any characteristic of the feed referred to in Article 16 (1) such as those indicated hereunder, which is not equivalent to its conventional counterpart:
nutritional properties,
nutritional properties,
intended use,
intended use,
implications for the health of certain species or categories of animals.
implications for the health of certain species or categories of animals.
as specified in the authorisation, any characteristic or property where a feed may give rise to ethical or religious concerns;
as specified in the authorisation, any characteristic or property where a feed may give rise to ethical or religious concerns;
where the feed consists of more than one ingredient and is a compound feedingstuff as defined in Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs
where the feed consists of more than one ingredient and is a compound feedingstuff as defined in Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs
, the words "genetically modified" or "produced from genetically modified [name of organism]" shall appear in the list of ingredients, provided for in Article 5c of that Directive, in parentheses immediately following the ingredient concerned.
, the words "genetically modified" or "produced from genetically modified [name of organism]" shall appear in the list of ingredients, provided for in Article 5c of that Directive, in parentheses immediately following the ingredient concerned.
In addition to the requirements laid down in paragraph 3(a) and (b) and as specified in the authorisation, the labelling
In addition to the requirements laid down in paragraph 3(a) and (b) and as specified in the authorisation, the labelling
accompanying documents of feed falling within the scope of this Section which
accompanying documents of feed falling within the scope of this Section which
not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned.
not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the feed concerned.
The Commission shall ensure that the requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production are no less rigorous for products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.
The Commission shall ensure that the requirements arising from the directives, regulations and administrative provisions concerning the evaluation and authorisation of food and feed and of raw materials intended for their production are no less rigorous for products imported into the European Union, in order to avoid the creation of unequal and unfair conditions of competition.
Chapter IV
Chapter IV
Common provisions Article 29
Common provisions Article 29
Products likely to be used as food and feed
Products likely to be used as food and feed
Where a product is likely to be used both as food and feed, a single application under
Where a product is likely to be used both as food and feed, a single application under
Articles 6 and 18
Articles 6 and 18
shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.
shall be submitted and shall give rise to a single opinion from the Authority and a single Community decision.
The Authority
The Authority
consider whether the application for authorisation should be submitted both as food and feed.
consider whether the application for authorisation should be submitted both as food and feed.
Article 30 Community Register
Article 30 Community Register
The Commission shall establish and maintain a Community Register of Genetically Modified Food and Feed, referred to in this Regulation as "the Register'.
The Commission shall establish and maintain a Community Register of Genetically Modified Food and Feed, referred to in this Regulation as "the Register'.
The Register shall include information on the method(s) validated by the Community reference laboratory, pursuant to Article 7(4)(f) and Article 19(4)(f), and on the methods used by the national reference laboratories.
The Register shall include information on the method(s) validated by the Community reference laboratory, pursuant to Article 7(4)(f) and Article 19(4)(f), and on the methods used by the national reference laboratories.
The Register shall be made available to the public.
The Register shall be made available to the public.
Article 31 Confidentiality
Article 31 Confidentiality
The applicant may indicate which information submitted under
The applicant may indicate which information submitted under
Regulation he wishes to be treated as confidential because its disclosure may significantly harm
Regulation he wishes to be treated as confidential because its disclosure may significantly harm
competitive position.
competitive position.
Verifiable justification must be given in such cases.
Verifiable justification must be given in such cases.
Without prejudice to paragraph 3, the Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.
Without prejudice to paragraph 3, the Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant of its decision.
Information relating to the following shall not be considered confidential:
Information relating to the following shall not be considered confidential:
name and composition of the genetically modified organism, food or feed referred to in
name and composition of the genetically modified organism, food or feed referred to in
16(1) and, where appropriate, indication of the substrate and the micro-organism;
16(1) and, where appropriate, indication of the substrate and the micro-organism;
general description of the genetically modified organism and the name and address of the authorisation-holder;
general description of the genetically modified organism and the name and address of the authorisation-holder;
physico-chemical and biological characteristics of the genetically modified organism, food or feed referred to in
physico-chemical and biological characteristics of the genetically modified organism, food or feed referred to in
effects of the genetically modified organism, food or feed referred to in
effects of the genetically modified organism, food or feed referred to in
16(1) on human and animal health and on the environment;
16(1) on human and animal health and on the environment;
16(1) on the characteristics of animal products and
16(1) on the characteristics of animal products and
nutritional properties;
nutritional properties;
methods 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 or feed referred to in
methods 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 or feed referred to in
16(1) and, where applicable, monitoring requirements and a summary of the results of the monitoring;
16(1) and, where applicable, monitoring requirements and a summary of the results of the monitoring;
information on waste treatment and emergency response.
information on waste treatment and emergency response.
Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.
Notwithstanding paragraph 2, the Authority shall on request supply the Commission and Member States with all information in its possession.
The Commission, the Authority and the Member States shall keep confidential all the information identified as confidential under paragraph 2 except for information which must be made public if circumstances so require, in order to protect human health, animal health or the environment.
The Commission, the Authority and the Member States shall keep confidential all the information identified as confidential under paragraph 2 except for information which must be made public if circumstances so require, in order to protect human health, animal health or the environment.
If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Authority and the applicant disagree as to its confidentiality.
If an applicant withdraws or has withdrawn an application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information as well as information on which the Authority and the applicant disagree as to its confidentiality.
Article 32 Data protection
Article 32 Data protection
The scientific data and other information in the application dossier required under
The scientific data and other information in the application dossier required under
(3) and (5) may not be used for the benefit of another applicant for a period of ten years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used.
(3) and (5) may not be used for the benefit of another applicant for a period of ten years from the date of authorisation, unless the other applicant has agreed with the authorisation-holder that such data and information may be used.
On expiry of this ten-
On expiry of this ten-