natgillin/translations-raw huggingface dataset:
The major philosophical shift in Directive 2001/18/EC compared to its predecessors is the explicit adoption of the precautionary approach as a guide, rather than or in addition to the concepts of familiarity and substantial equivalence.
The major philosophical shift in Directive 2001/18/EC compared to its predecessors is the explicit adoption of the precautionary approach as a guide, rather than or in addition to the concepts of familiarity and substantial equivalence.
The EC realises that the precautionary approach may be difficult to apply.
The EC realises that the precautionary approach may be difficult to apply.
Therefore, it is stated that reliance on the precautionary approach is no excuse for detracting from the general principles of risk management such as proportionality, non discrimination, consistency, examination of the benefits and costs of action or lack of action and examination of scientific developments (CEC, 2000).
Therefore, it is stated that reliance on the precautionary approach is no excuse for detracting from the general principles of risk management such as proportionality, non discrimination, consistency, examination of the benefits and costs of action or lack of action and examination of scientific developments (CEC, 2000).
This is being interpreted in different ways by member states and also different EC Directorate Generals.
This is being interpreted in different ways by member states and also different EC Directorate Generals.
A public registry of all approved products will allow consumers to trace GM products.
A public registry of all approved products will allow consumers to trace GM products.
Although the basic philosophy of the regulation is quite different, the data requirements for assessing safety of GM plants and plant products are similar to the USA.
Although the basic philosophy of the regulation is quite different, the data requirements for assessing safety of GM plants and plant products are similar to the USA.
The information required in the EU tends to be more extensive, mainly with respect to molecular characterisation, impacts of the specific cultivation and management requirements of the GM crops, post market monitoring and traceability.
The information required in the EU tends to be more extensive, mainly with respect to molecular characterisation, impacts of the specific cultivation and management requirements of the GM crops, post market monitoring and traceability.
In addition to Directive 2001/18/EC, a range of other legislative documents deals with aspects of GM crop regulation in the EU.
In addition to Directive 2001/18/EC, a range of other legislative documents deals with aspects of GM crop regulation in the EU.
The placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs is governed by Regulation (EC) 1829/2003 on genetically modified food and feed.
The placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs is governed by Regulation (EC) 1829/2003 on genetically modified food and feed.
Where a food product contains or consists of GMOs, the applicant has a choice: either the application as a whole is subject solely to Regulation (EC) 1829/2003, in application of the principle of "one door, one key", in order to obtain authorisation for the deliberate release of a GMO into the environment - in accordance with the criteria laid down by Directive 2001/18/EC - and for the use of this GMO in food products - in accordance with the criteria laid down by Regulation (EC) 1829/2003; or the application - or part of it - is subject both to Directive 2001/18/EC and to Regulation (EC) 1829/2003.
Where a food product contains or consists of GMOs, the applicant has a choice: either the application as a whole is subject solely to Regulation (EC) 1829/2003, in application of the principle of "one door, one key", in order to obtain authorisation for the deliberate release of a GMO into the environment - in accordance with the criteria laid down by Directive 2001/18/EC - and for the use of this GMO in food products - in accordance with the criteria laid down by Regulation (EC) 1829/2003; or the application - or part of it - is subject both to Directive 2001/18/EC and to Regulation (EC) 1829/2003.
In addition, GM crop cultivars must pass a variety registration procedure and be listed in the Community Common Catalogue, before they are allowed to be grown commercially.
In addition, GM crop cultivars must pass a variety registration procedure and be listed in the Community Common Catalogue, before they are allowed to be grown commercially.
This is no different from the regulation for any new cultivar resulting from traditional breeding.
This is no different from the regulation for any new cultivar resulting from traditional breeding.
In Regulation EC/1139/98, the presence of DNA or protein resulting from genetic modification is used as a criterion to trigger labelling of food or food ingredients derived from GM maize and soybean.
In Regulation EC/1139/98, the presence of DNA or protein resulting from genetic modification is used as a criterion to trigger labelling of food or food ingredients derived from GM maize and soybean.
These labelling provisions were amended by Regulation EC/49/2000 to provide a 0.9%-labelling threshold for “adventitious”, “accidental” or “technically unavoidable” presence of GM material in food (during cultivation, harvest, handling, transport or processing).
These labelling provisions were amended by Regulation EC/49/2000 to provide a 0.9%-labelling threshold for “adventitious”, “accidental” or “technically unavoidable” presence of GM material in food (during cultivation, harvest, handling, transport or processing).
In addition, Regulation EC/50/2000 defines specific labelling requirements for food and food ingredients containing additives, colourings and flavourings derived from GM material.
In addition, Regulation EC/50/2000 defines specific labelling requirements for food and food ingredients containing additives, colourings and flavourings derived from GM material.
The EC has presented legislation on traceability and labelling of GM organisms and products derived from GM organisms and for GM food and feed.
The EC has presented legislation on traceability and labelling of GM organisms and products derived from GM organisms and for GM food and feed.
These require traceability throughout the whole production chain at all stages of the market.
These require traceability throughout the whole production chain at all stages of the market.
It will provide consumers with information by labelling all GM food and feed.
It will provide consumers with information by labelling all GM food and feed.
All foods in which GM organisms are contained, or have been produced from GM organisms, should be labelled.
All foods in which GM organisms are contained, or have been produced from GM organisms, should be labelled.
In the United States
In the United States
In the USA the regulation focuses primarily on the characteristics of the product, rather than the way in which the product is produced.
In the USA the regulation focuses primarily on the characteristics of the product, rather than the way in which the product is produced.
This product-based assessment is a major difference with the philosophy of regulation in for example the European Union, which is process-based.
This product-based assessment is a major difference with the philosophy of regulation in for example the European Union, which is process-based.
This process-product difference of philosophy has sparked considerable controversy over recent years.
This process-product difference of philosophy has sparked considerable controversy over recent years.
In the USA regulation of the environmental release is based on the concept of “familiarity”.
In the USA regulation of the environmental release is based on the concept of “familiarity”.
This concept can be considered the ecological counterpart of the concept of “substantial equivalence”, although in some publications these two concepts are also considered separately for environmental release.
This concept can be considered the ecological counterpart of the concept of “substantial equivalence”, although in some publications these two concepts are also considered separately for environmental release.
Familiarity considers whether the GM plant is comparable to its traditionally bred counterpart in environmental safety.
Familiarity considers whether the GM plant is comparable to its traditionally bred counterpart in environmental safety.
Such comparison may assess the relevant issues in a GM crop without direct experience.
Such comparison may assess the relevant issues in a GM crop without direct experience.
Familiarity considers the biology of the plant species, the trait introduced, and the agricultural practices and environment used for crop production.
Familiarity considers the biology of the plant species, the trait introduced, and the agricultural practices and environment used for crop production.
USA has separate regulations governing releases of plants for pharmaceutical and bioremediation purposes but has no regulations concerning labelling and traceability of GM crops.
USA has separate regulations governing releases of plants for pharmaceutical and bioremediation purposes but has no regulations concerning labelling and traceability of GM crops.
Farming of GM crops
Farming of GM crops
The approval of GM crops is quite long-lasting and complex.
The approval of GM crops is quite long-lasting and complex.
But the practical farming also faces many rules and restrictions.
But the practical farming also faces many rules and restrictions.
They concern labelling, traceability, co-existence, liability and compensations.
They concern labelling, traceability, co-existence, liability and compensations.
These rules have no counterparts if you grow conventionally bred crops.
These rules have no counterparts if you grow conventionally bred crops.
Labelling and traceability have already been dealt with previously.
Labelling and traceability have already been dealt with previously.
Since the publication of the Commission Recommendations and guidelines for co-existence of genetically modified, conventional and organic farming in July 2003 all Member States are developing co-existence strategies under the subsidiarity principle.
Since the publication of the Commission Recommendations and guidelines for co-existence of genetically modified, conventional and organic farming in July 2003 all Member States are developing co-existence strategies under the subsidiarity principle.
Concerning co-existence there are great demands to create GM-free regions or member states in the EU.
Concerning co-existence there are great demands to create GM-free regions or member states in the EU.
Until now the general position has been that these are not legal, if there is no scientific evidence, not according to the EU law or under international agreements.
Until now the general position has been that these are not legal, if there is no scientific evidence, not according to the EU law or under international agreements.
There are some cases in the Court of European Justice waiting for decision.
There are some cases in the Court of European Justice waiting for decision.
It might be worth mentioning that at the same time when several regions have announced their intention to be a GM- free region, imported GM – feed is used in animal husbandry.
It might be worth mentioning that at the same time when several regions have announced their intention to be a GM- free region, imported GM – feed is used in animal husbandry.
There is also a diverse variety of applications of the co-existence in different member states.
There is also a diverse variety of applications of the co-existence in different member states.
A single European model does not exist, which will probably cause disputes and difficulties in the single markets.
A single European model does not exist, which will probably cause disputes and difficulties in the single markets.
The Commission has left the issue as a matter of subsidiary to the hands of member states and tries to promote best practices in this matter.
The Commission has left the issue as a matter of subsidiary to the hands of member states and tries to promote best practices in this matter.
The results are not very promising.
The results are not very promising.
A big issue is liability re co-existence.
A big issue is liability re co-existence.
The main issue is who is liable, who can claim, what can be claimed and under what circumstances and whether there is a compensation fund or insurance to cover any claims.
The main issue is who is liable, who can claim, what can be claimed and under what circumstances and whether there is a compensation fund or insurance to cover any claims.
Only Spain has previously applied general law to liability, but now nearly all member states are approaching the issue on the bases of the way of breeding separating GM crops from conventionally bred crops.
Only Spain has previously applied general law to liability, but now nearly all member states are approaching the issue on the bases of the way of breeding separating GM crops from conventionally bred crops.
When conventionally bred crops are grown, general law is applied on liability and compensations, if damage has been causes.
When conventionally bred crops are grown, general law is applied on liability and compensations, if damage has been causes.
The somewhat unclear question of liability may provoke complaints that are expensive to investigate and in that way discourage some farmers from starting the cultivation of GM crops.
The somewhat unclear question of liability may provoke complaints that are expensive to investigate and in that way discourage some farmers from starting the cultivation of GM crops.
GMO and international agreements
GMO and international agreements
In 29 September 2006 the WTO made public the dispute panel verdict on the European Union's six-year moratorium on imports of genetically modified food and crops.
In 29 September 2006 the WTO made public the dispute panel verdict on the European Union's six-year moratorium on imports of genetically modified food and crops.
Regarding the alleged moratorium on the approval of GMOs, the Panel found that the EC had applied a de facto moratorium between June 1999 and August 2003.
Regarding the alleged moratorium on the approval of GMOs, the Panel found that the EC had applied a de facto moratorium between June 1999 and August 2003.
As a legal matter, this moratorium was considered to be inconsistent with the EC's obligation under Annex C(1)(a) of the SPS (Sanitary and phytosanitary agreement on international standards for harmonised food safety standards), which requires parties to complete testing and approval procedures without undue delay.
As a legal matter, this moratorium was considered to be inconsistent with the EC's obligation under Annex C(1)(a) of the SPS (Sanitary and phytosanitary agreement on international standards for harmonised food safety standards), which requires parties to complete testing and approval procedures without undue delay.
Regarding the complaint that the EC had failed to consider specific GMOs for approval, the Panel ruled that the EC had acted inconsistently with its obligation under Annex C(1)(a) to undertake and complete such procedures without undue delay with respect to numerous GMOs.
Regarding the complaint that the EC had failed to consider specific GMOs for approval, the Panel ruled that the EC had acted inconsistently with its obligation under Annex C(1)(a) to undertake and complete such procedures without undue delay with respect to numerous GMOs.
Under the U.S. complaint, the Panel found undue delay in the EC's consideration of 21 out of 25 specified GMOs.
Under the U.S. complaint, the Panel found undue delay in the EC's consideration of 21 out of 25 specified GMOs.
For Canada, the inconsistent treatment was found for all four GMOs identified.
For Canada, the inconsistent treatment was found for all four GMOs identified.
Regarding the individual European country bans on GMO products ( including Safeguard Measures), the Panel condemned the ban by six EU members (Austria, Belgium, France, Germany, Italy and Luxembourg) on a number of individual products.
Regarding the individual European country bans on GMO products ( including Safeguard Measures), the Panel condemned the ban by six EU members (Austria, Belgium, France, Germany, Italy and Luxembourg) on a number of individual products.
The Panel ruled that the bans were not based on risk assessments as required by Article 5.1 of the SPS Agreement, and were therefore inconsistent with the countries' WTO obligations.
The Panel ruled that the bans were not based on risk assessments as required by Article 5.1 of the SPS Agreement, and were therefore inconsistent with the countries' WTO obligations.
The conclusions reached in this aspect of the decision were the only ones in which the Panel found breaches of substantive, rather than merely procedural, provisions of the SPS Agreement.
The conclusions reached in this aspect of the decision were the only ones in which the Panel found breaches of substantive, rather than merely procedural, provisions of the SPS Agreement.
Significantly, the Panel found that the bans were not consistent with Article 5.7 of the SPS, which permits parties to adopt provisional measures (such as product bans) where there is insufficient scientific evidence to assess the risk of the product.
Significantly, the Panel found that the bans were not consistent with Article 5.7 of the SPS, which permits parties to adopt provisional measures (such as product bans) where there is insufficient scientific evidence to assess the risk of the product.
The EC Scientific Committee on Plants and competent national authorities had carried out assessments of each of the products in question, and each was approved as safe.
The EC Scientific Committee on Plants and competent national authorities had carried out assessments of each of the products in question, and each was approved as safe.
These assessments were deemed to be proper risk assessments as defined in the SPS Agreement.
These assessments were deemed to be proper risk assessments as defined in the SPS Agreement.
The studies relied upon by the individual countries for their bans were found not to constitute sufficient risk assessments and, because acceptable risk assessments were available, Article 5.7 could not be relied upon.
The studies relied upon by the individual countries for their bans were found not to constitute sufficient risk assessments and, because acceptable risk assessments were available, Article 5.7 could not be relied upon.
This in turn led the Panel to conclude that these country bans were also inconsistent with Articles 2.2 and 2.3 of the SPS, which prohibit a party from maintaining a restrictive measure without sufficient scientific evidence to justify it (Article 2.2), and from applying such measures in a way to constitute a disguised restriction on international trade (Article 2.3).
This in turn led the Panel to conclude that these country bans were also inconsistent with Articles 2.2 and 2.3 of the SPS, which prohibit a party from maintaining a restrictive measure without sufficient scientific evidence to justify it (Article 2.2), and from applying such measures in a way to constitute a disguised restriction on international trade (Article 2.3).
The Panel recommended that the individual countries bring their safeguard measures into compliance, and remove the bans on the specified GMO products.
The Panel recommended that the individual countries bring their safeguard measures into compliance, and remove the bans on the specified GMO products.
While the WTO Panel did not pronounce on the validity of the EC's regulatory system for GMOs, it did rule that bans on GMO products that are not based on risk assessments, as defined in the SPS, are inconsistent with WTO rules.
While the WTO Panel did not pronounce on the validity of the EC's regulatory system for GMOs, it did rule that bans on GMO products that are not based on risk assessments, as defined in the SPS, are inconsistent with WTO rules.
On the other hand, the Panel confirmed the right of individual countries to impose bans if risk assessments support such measures.
On the other hand, the Panel confirmed the right of individual countries to impose bans if risk assessments support such measures.
Regarding the moratorium on approvals of GMO products, the Panel did find that the 1999-2003 moratorium was inconsistent with the SPS Agreement, as it had the effect of unduly delaying the results of the approvals process.
Regarding the moratorium on approvals of GMO products, the Panel did find that the 1999-2003 moratorium was inconsistent with the SPS Agreement, as it had the effect of unduly delaying the results of the approvals process.
The Panel did not suggest that future moratoria would necessarily also be inconsistent.
The Panel did not suggest that future moratoria would necessarily also be inconsistent.
If additional scientific evidence were brought to light that would justify restrictions, the EC would be permitted to impose them, provided decisions were made without undue delay.
If additional scientific evidence were brought to light that would justify restrictions, the EC would be permitted to impose them, provided decisions were made without undue delay.
In its ruling, the Panel interpreted the obligations of the SPS agreement without reference to any precautionary approach and reaffirmed that restrictive measures said to be based on health or environmental concerns have to be justified by science, and not on concerns or desires to be cautious.
In its ruling, the Panel interpreted the obligations of the SPS agreement without reference to any precautionary approach and reaffirmed that restrictive measures said to be based on health or environmental concerns have to be justified by science, and not on concerns or desires to be cautious.
pursuant to Rule 48(3) of the Rules of Procedure
pursuant to Rule 48(3) of the Rules of Procedure
Diamanto Manolakou and Ilda Figueiredo
Diamanto Manolakou and Ilda Figueiredo
on behalf of GUE/NGL
on behalf of GUE/NGL
Whereas according to a recent Eurobarometer study 70% of the population in the EU rejects the consumption of GM food and that many regions and entire member states are declaring themselves "GM free",
Whereas according to a recent Eurobarometer study 70% of the population in the EU rejects the consumption of GM food and that many regions and entire member states are declaring themselves "GM free",
Whereas different studies, show that coexistence between transgenic and conventional/organic crops is impossible, considers that genetic engineering is a defective and uncontrollable technology incompatible with agricultural sustainability,
Whereas different studies, show that coexistence between transgenic and conventional/organic crops is impossible, considers that genetic engineering is a defective and uncontrollable technology incompatible with agricultural sustainability,
Considers that intellectual property rights (e.g. patented seeds) concentrate in a few multinational corporations' increases their power and control over food sovereignty, food safety and farmers, leading to impoverished varietal diversity in Europe, reduce biodiversity, as well the concentration and intensification of production and abandonment of rural areas.
Considers that intellectual property rights (e.g. patented seeds) concentrate in a few multinational corporations' increases their power and control over food sovereignty, food safety and farmers, leading to impoverished varietal diversity in Europe, reduce biodiversity, as well the concentration and intensification of production and abandonment of rural areas.
Stresses the need to apply the precautionary principle and considers that information on the risks from GMOs have been supplied essentially by the GMO industry.
Stresses the need to apply the precautionary principle and considers that information on the risks from GMOs have been supplied essentially by the GMO industry.