natgillin/translations-raw huggingface dataset:
This scientific evaluation should be followed by a risk management decision by the Community, under a regulatory procedure ensuring close co-operation between the Commission and the Member States.
This scientific evaluation should be followed by a risk management decision by the Community, under a regulatory procedure ensuring close co-operation between the Commission and the Member States.
Experience has shown that authorisation should not be granted for a single use, when a product is likely to be used both for food and feed purposes; therefore such products should only be authorised when fulfilling authorisation criteria for both food and feed.
Experience has shown that authorisation should not be granted for a single use, when a product is likely to be used both for food and feed purposes; therefore such products should only be authorised when fulfilling authorisation criteria for both food and feed.
Under this Regulation, authorisation may be granted either to a GMO and products for food and/or feed use which
Under this Regulation, authorisation may be granted either to a GMO and products for food and/or feed use which
consist of, contain
consist of, contain
or are produced from it, or to foods or feed produced from a GMO.
or are produced from it, or to foods or feed produced from a GMO.
Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed
Thus, where a GMO used in the production of food and/or feed has been authorised under this Regulation, foods and/or feed
consisting of, containing
consisting of, containing
or produced from that GMO do not need an authorisation under this Regulation, but are subject to the requirements laid down in the authorisation granted in respect of the GMO.
or produced from that GMO do not need an authorisation under this Regulation, but are subject to the requirements laid down in the authorisation granted in respect of the GMO.
Furthermore, foods covered by an authorisation granted under this Regulation are exempted from the requirements of Regulation (EC) No
Furthermore, foods covered by an authorisation granted under this Regulation are exempted from the requirements of Regulation (EC) No
where they fall under one or more of the categories laid down in Article 1 (2) (a) of
where they fall under one or more of the categories laid down in Article 1 (2) (a) of
that Regulation in
that Regulation in
respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.
respect of a characteristic which has not been considered for the purpose of the authorisation granted under this Regulation.
Council Directive 89/107/EEC of 21 December 1988
Council Directive 89/107/EEC of 21 December 1988
on the approximation of the laws of the Member States
on the approximation of the laws of the Member States
concerning food additives authorised for use in foodstuffs intended for human
concerning food additives authorised for use in foodstuffs intended for human
for authorisation of additives used in foodstuffs.
for authorisation of additives used in foodstuffs.
In addition to this authorisation procedure, food additives
In addition to this authorisation procedure, food additives
or produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 89/107/EEC.
or produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 89/107/EEC.
Flavourings falling under the scope of Council Directive 88/388/EEC of 22 June 1988
Flavourings falling under the scope of Council Directive 88/388/EEC of 22 June 1988
relating to flavourings for use in foodstuffs
relating to flavourings for use in foodstuffs
and to source materials for their production
and to source materials for their production
consist of
consist of
or are produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification.
or are produced from GMOs should fall also under the scope of this Regulation for the safety assessment of the genetic modification.
Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal
Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal
OJ L 213, 21.7.1982, p. 8.
OJ L 213, 21.7.1982, p.
for an approval procedure for feed materials produced using different technologies that may pose risk to human or animal health and the environment; these feed materials
for an approval procedure for feed materials produced using different technologies that may pose risk to human or animal health and the environment; these feed materials
or produced from GMOs should fall instead under the scope of this Regulation.
or produced from GMOs should fall instead under the scope of this Regulation.
Council Directive 70/524/EEC of 23 November 1970 concerning additives in
Council Directive 70/524/EEC of 23 November 1970 concerning additives in
Directive as last amended by Directive 1999/20/EC
Directive as last amended by Directive 1999/20/EC
for an authorisation procedure for placing on the market additives used in feedingstuffs.
for an authorisation procedure for placing on the market additives used in feedingstuffs.
In addition to this authorisation procedure, feed additives
In addition to this authorisation procedure, feed additives
or produced from GMOs should
or produced from GMOs should
fall also
fall also
under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 70/524/EEC.
under the scope of this Regulation for the safety assessment of the genetic modification, while the final authorisation should be granted under the procedure laid down in Directive 70/524/EEC.
This Regulation covers food and feed produced "from" a GMO but not food and feed "with" a GMO.
This Regulation covers food and feed produced "from" a GMO but not food and feed "with" a GMO.
The determining criterion is whether or not material derived from the genetically modified starting material is present in the food or in the feed.
The determining criterion is whether or not material derived from the genetically modified starting material is present in the food or in the feed.
Processing aids as defined in Council Directive 89/107/EEC, which are only used during the food or feed production process, are not covered by the definition of food or feed and, therefore, are not included in the scope of this Regulation.
Processing aids as defined in Council Directive 89/107/EEC, which are only used during the food or feed production process, are not covered by the definition of food or feed and, therefore, are not included in the scope of this Regulation.
Nor are food and feed which are manufactured with the help of a genetically modified processing aid.
Nor are food and feed which are manufactured with the help of a genetically modified processing aid.
Thus, food produced with a genetically modified enzyme that does not remain in the final product and products obtained from animals fed with genetically modified feed or treated with genetically modifed medicinal products will be subject neither to the authorisation requirements, nor to the labelling requirements laid down in this Regulation.
Thus, food produced with a genetically modified enzyme that does not remain in the final product and products obtained from animals fed with genetically modified feed or treated with genetically modifed medicinal products will be subject neither to the authorisation requirements, nor to the labelling requirements laid down in this Regulation.
In accordance with Article 153 of the Treaty, the Community shall contribute to
In accordance with Article 153 of the Treaty, the Community shall contribute to
the right of consumers to information.
the right of consumers to information.
Additional to other types of information to the public established in this Regulation, labelling of products is a means that enables the consumer to make an informed choice and facilitates fairness of transactions between seller and purchaser.
Additional to other types of information to the public established in this Regulation, labelling of products is a means that enables the consumer to make an informed choice and facilitates fairness of transactions between seller and purchaser.
requires that the labelling must not mislead the
requires that the labelling must not mislead the
purchaser as
purchaser as
to the characteristics of the foodstuff
to the characteristics of the foodstuff
particular, as to its nature, identity, properties, composition, method of manufacture or production,
particular, as to its nature, identity, properties, composition, method of manufacture or production,
Additional requirements for the labelling of genetically modified foods are laid down in Regulation (EC) No
Additional requirements for the labelling of genetically modified foods are laid down in Regulation (EC) No
in Council
in Council
Regulation (EC) No 1139/98
Regulation (EC) No 1139/98
of 26 May 1998
of 26 May 1998
concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive
concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive
OJ L 159, 3.6.1998, p. 4.
OJ L 159, 3.6.1998, p.
Regulation (EC) No 50/2000
Regulation (EC) No 50/2000
of 10 January 2000
of 10 January 2000
Harmonised labelling requirements should be laid down for genetically modified feed to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed, which enable the user to make an informed choice.
Harmonised labelling requirements should be laid down for genetically modified feed to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed, which enable the user to make an informed choice.
The labelling should include objective information that a food or feed consists of, contains or is produced from GMOs; clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards method of manufacture or production.
The labelling should include objective information that a food or feed consists of, contains or is produced from GMOs; clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards method of manufacture or production.
Additionally, the labelling should inform about any characteristic or property which renders a food or feed not equivalent to its conventional counterpart in respect
Additionally, the labelling should inform about any characteristic or property which renders a food or feed not equivalent to its conventional counterpart in respect
composition, nutritional value or nutritional effects, intended use of the food or feed and health implications
composition, nutritional value or nutritional effects, intended use of the food or feed and health implications
certain sections of the population, as well as any characteristic or property which gives rise to ethical or religious concerns.
certain sections of the population, as well as any characteristic or property which gives rise to ethical or religious concerns.
of the European Parliament and of the Council
of the European Parliament and of the Council
concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms
concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms
OJ L
OJ L
ensures that the specific information concerning the genetic modification is available at each stage of the placing on the market of GMOs and food and feed produced
ensures that the specific information concerning the genetic modification is available at each stage of the placing on the market of GMOs and food and feed produced
and should thereby facilitate accurate labelling.
and should thereby facilitate accurate labelling.
Despite the fact that some operators avoid using genetically modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable contamination during cultivation, harvest, transport and processing; in such cases, this food or feed should not be subject to the labelling requirements of this Regulation; in order to achieve this objective, it is necessary to establish thresholds for the adventitious or technically unavoidable presence of genetically modified material in foods or feed.
Despite the fact that some operators avoid using genetically modified food and feed, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable contamination during cultivation, harvest, transport and processing; in such cases, this food or feed should not be subject to the labelling requirements of this Regulation; in order to achieve this objective, it is necessary to establish thresholds for the adventitious or technically unavoidable presence of genetically modified material in foods or feed.
In order to establish that the presence of this material is adventitious or technically unavoidable, operators
In order to establish that the presence of this material is adventitious or technically unavoidable, operators
must demonstrate
must demonstrate
to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.
to the competent authorities that they have taken appropriate steps to avoid the presence of the genetically modified food or feed.
In order to ensure the practicability and feasibility of this Regulation, a threshold of
In order to ensure the practicability and feasibility of this Regulation, a threshold of
%, with the possibility of establishing lower levels, should be established for minute traces in food or feed of genetically modified
%, with the possibility of establishing lower levels, should be established for minute traces in food or feed of genetically modified
material authorised
material authorised
under Community legislation, where the presence of such material is adventitious or technically unavoidable;
under Community legislation, where the presence of such material is adventitious or technically unavoidable;
as and when advances in science and technology allow, appropriately lower thresholds should be established
as and when advances in science and technology allow, appropriately lower thresholds should be established
Member States should encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination by genetically modified material.
Member States should encourage and contribute to the drawing up of guides to good segregation practice to be applied by food operators in order to avoid adventitious or technically unavoidable contamination by genetically modified material.
It is necessary to establish harmonised procedures for risk assessment and authorisation, that are efficient, time-limited and transparent, and criteria for evaluation of the potential risks arising from genetically modified foods and feed.
It is necessary to establish harmonised procedures for risk assessment and authorisation, that are efficient, time-limited and transparent, and criteria for evaluation of the potential risks arising from genetically modified foods and feed.
In order to ensure a harmonised scientific assessment of genetically modified foods and feed, such assessments should be carried out by the European Food
In order to ensure a harmonised scientific assessment of genetically modified foods and feed, such assessments should be carried out by the European Food
It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.
It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other legitimate factors relevant to the matter under consideration may be taken into account.
Risks to the environment may be associated with foods and feed which
Risks to the environment may be associated with foods and feed which
consist of or contain
consist of or contain
Part C of Directive 2001/18/EC provides that no product consisting of or containing a GMO may be placed on the market without inter alia a risk assessment having been carried out in accordance with that part of the Directive.
Part C of Directive 2001/18/EC provides that no product consisting of or containing a GMO may be placed on the market without inter alia a risk assessment having been carried out in accordance with that part of the Directive.
However, that requirement is waived in respect of any product covered by sectoral Community legislation that provides for a specific environmental risk assessment at least equivalent to the environmental risk assessment carried out in accordance with Annexes II and III to that Directive.
However, that requirement is waived in respect of any product covered by sectoral Community legislation that provides for a specific environmental risk assessment at least equivalent to the environmental risk assessment carried out in accordance with Annexes II and III to that Directive.
This Regulation should satisfy the conditions for the waiver to apply the requirements of that Directive.
This Regulation should satisfy the conditions for the waiver to apply the requirements of that Directive.
It is therefore also necessary that its provisions in regard to risk management, labelling, monitoring, information to the public and safeguard clause, must be at least equivalent to those laid down in Directive 2001/18/EC.
It is therefore also necessary that its provisions in regard to risk management, labelling, monitoring, information to the public and safeguard clause, must be at least equivalent to those laid down in Directive 2001/18/EC.
It is necessary to introduce, where appropriate and based on the conclusions of the risk assessment, post-market monitoring requirements for the use of the genetically modified foods for human consumption and for the use of the genetically modified feed for animal consumption.
It is necessary to introduce, where appropriate and based on the conclusions of the risk assessment, post-market monitoring requirements for the use of the genetically modified foods for human consumption and for the use of the genetically modified feed for animal consumption.
In the case of genetically modified organisms, a monitoring plan concerning environment effects is compulsory in accordance with Directive 2001/18/EC.
In the case of genetically modified organisms, a monitoring plan concerning environment effects is compulsory in accordance with Directive 2001/18/EC.
To facilitate controls on genetically modified foods and feed, applicants for authorisation should propose appropriate methods of sampling and detection, and deposit samples of the genetically modified food and feed with the European Food
To facilitate controls on genetically modified foods and feed, applicants for authorisation should propose appropriate methods of sampling and detection, and deposit samples of the genetically modified food and feed with the European Food
Authority; methods of sampling and detection should be validated, where appropriate, by the Community reference laboratory.
Authority; methods of sampling and detection should be validated, where appropriate, by the Community reference laboratory.
Technological progress and scientific developments should be taken into account when implementing this Regulation.
Technological progress and scientific developments should be taken into account when implementing this Regulation.
Existing authorisations and notifications for placing on the market genetically modified foods under Regulation (EC) No
Existing authorisations and notifications for placing on the market genetically modified foods under Regulation (EC) No
258/97 and
258/97 and
existing authorisations of genetically modified food and feed, granted under Directives 90/220/EEC and 2001/18/EC, Directive 82/471/EEC or Directive 70/524/EEC, should continue to remain in force, subject to that the European Food
existing authorisations of genetically modified food and feed, granted under Directives 90/220/EEC and 2001/18/EC, Directive 82/471/EEC or Directive 70/524/EEC, should continue to remain in force, subject to that the European Food
Authority is provided with information concerning the risk assessment, methods for sampling and detection as appropriate, including samples of the food and feed and their control samples within six months of the entry into force of this Regulation.
Authority is provided with information concerning the risk assessment, methods for sampling and detection as appropriate, including samples of the food and feed and their control samples within six months of the entry into force of this Regulation.
A register of genetically modified food and feed authorised under this Regulation shall be established, including product specific information,
A register of genetically modified food and feed authorised under this Regulation shall be established, including product specific information,
studies which demonstrate the safety of the product, and sampling and detection methods; non-confidential data should be made available to the public.
studies which demonstrate the safety of the product, and sampling and detection methods; non-confidential data should be made available to the public.
In order to stimulate research and development into genetically modified organisms for food and/or feed use, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application under this Regulation.
In order to stimulate research and development into genetically modified organisms for food and/or feed use, it is appropriate to protect the investment made by innovators in gathering the information and data supporting an application under this Regulation.
This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials which should be against the public interest.
This protection should however be limited in time in order to avoid the unnecessary repetition of studies and trials which should be against the public interest.
The Commission shall be assisted by the Committee referred to in
The Commission shall be assisted by the Committee referred to in
Article 58
Article 58
(1) of Regulation (EC) No
(1) of Regulation (EC) No