“GMOs Regulation in the European Union”
(6th updating/December 2011)
A detailed and critical review of the EU legal framework
regulating the different activities with GMOs
Author: Juan José PEINADO VACAS (Agricultural Technician)
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INDEX
Foreword………………………………………………………………………………3
Introduction…………………………………………………………………………...4
List of GMO Legal Acts (commented)………………………………………………9
A.- International Treaties and Conventions
A.I.- International Treaties and Conventions.....................................................9
A.II.-EU Legal Acts related to International Treaties and Conventions …….10
B.- European Union Legislation
B.I.- General legislation………………………………………………………11
B.II.- Contained use of GMMs legislation…………………………………….13
B.III.- Deliberate release of GMOs legislation……………………………….13
B.IV.- GMOs authorisation decisions………………………………………....18
B.V.- GM food and feed legislation………………………………………….. 33
B.VI.- Coexistence……………………………………………………………. 42
B.VII.- GMOs in sectoral legislation………………………………………….43
B.VIIa).- Agricultural Organic production……………………………43
B.VIIb).- Medicinal products for human and veterinarian use………. 44
B.VIIc).- Plant protection and Biocidal products……………………. 45
B.VIId).- Seed and Propagating material……………………………. 47
Common Catalogue of varieties of agricultural plant species……………………49
List of GM varieties in the Common Catalogue………………………………….. 53
References………………………………………………………………………… 60
Annex: Chronological List of Legal Acts………………………………………… 61
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“Where there is hunger and misery, the seed of terrorism takes
root”. Norman Borlaug.
“You have to have at least one square meal a day to be a
conservationist or an environmentalist”. Richard Leakey.
FOREWORD:
This
article
was
originally
published
(in
Spanish)
in
January
2007
in
www.agrodigital.com and since then has been periodically updated. The Spanish
version of the document includes also the Spanish National GMO’s legislation. This
English version has been, I must confess, an endurance exercise for me due to my poor
English and it will be also an endurance exercise to future possible readers (due to the
same reason).
The main aim of the document is to differ from the usual cold and aseptic compilation
(more or less completed) of the different juridical acts which form the legal framework
of any productive activity, but carefully avoiding a single critical comment or precision,
even in those situations where it is clear that the development of this legal framework
has been, for instance, politically conditioned.
The document, as can be seen, is a compilation (pretty exhaustive) of the legal acts
(individually commented) which have regulated the different activities with Genetically
Modified Organisms (GMOs) in the European Union. These legal acts are classified in
different areas: International Treaties and Conventions; Contained use of GM microorganisms; Deliberated release into the environment of GMOs; Authorisations and
authorisation procedure; Food and Feed; Coexistence, etc..
Legal acts already repealed have not been included (except those legal acts repealed
after the last updating of the document wich are maintained in it until its next updating,
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but crossed out and coloured in green), even though some of them, for instance:
Council Directive 90/220/EEC is a recurrent reference in the whole GMOs regulation
because, as you can see in Section B-IV, all GMOs -“events/traits”- authorisations
before 1998 were done pursuant to this Directive (before the EU blocked the approval
of new GMOs by way of a so called “moratorium”).
I would like to finish this Foreword expressing my gratitude to Javier Guedeja-Marron
Peinado (Veterinarian and Public Health Graduate) for his invaluable opinions and
suggestions in relation with veterinarian and public health items.
INTRODUCTION
Personal considerations on the development of the European Union legal framework
regulating activitivities with Genetically Modified Organisms (GMOs).
The legal framework for the regulation of the different activities with GMOs in
the EU was initiated by the entering into force of: Council Directive 90/219/EEC on the
contained use of genetically modified micro-organisms and Council Directive
90/220/EEC on the deliberate release into the environment of genetically modified
organisms.
Since then the implementation by the different Member States, of the provisions
for the authorisation of the contained use of the genetically modified micro-organisms
(GMM) and the much more polemical authorisation of the deliberate release of GMOs
(for research and development and for marketing purposes too) have gone on.
The development of the GMOs regulation framework during the following years
was more or less coherent and in accordance with a logical and predetermined strategy.
To this end the basic Directives above mentioned were accordingly adapted to the
technical progress and those items which had been more questioned were deeply
reviewed (i.e.: antibiotic-resistance genes). This dynamic led to the publication of:
Directive 2009/41/CE and Council Directive 2001/18/EC which replaced (updating
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their content) and repealed, respectively, Directive 90/219/EEC and Directive
90/220/EC. The technical aspect more questioned (i.e: antibiotic resistance genes) were
deeply reviewed.
In the beginning, the placing on the EU market of a product “containing” or
“consisting of” a genetically modified organism required: firstly the approval of the
genetic modification (“event”) by way of the “horizontal” or general regulation
(Council Directive 90/220/EEC and Council Directive 2001/18/EC from March 2001)
detailing the possible uses, and secondly the approval of the GM product (use
authorised) implementing the provisions of the EU legal framework regulating that kind
of GM product -or use- approved (“sectoral” legislation).
Departing from this legal approach, the first product containing a GMO (a
veterinarian vaccine) was approved in 1992 (see B-IV-3) and from this moment
onwards different GMOs were gradually authorised in the EU without relevant
opposition.
However, Article 10 of the Directive 90/220/EEC (Article 12 in the Directive
2001/18/EEC) foresaw (in accordance with the above mentioned logical and coherent
strategy) the gradual revision of the different sectoral regulations in order to provide
them, as soon as possible, with an environmental risk assessment procedure (and other
relevant technical elements) analogous to those laid down in Directive 90/220/EEC.
This would allow that the authorisation for placing on the market of a GM product for a
certain use, could be done implementing, exclusively, the accordingly reviewed sectoral
legislation regulating this specific use.
With this aim (rooted on the principle: “one door, one key”) the European
Commission started an ambitious working programme (compiled in the White Paper on
Food Safety) in order to proceed, in accordance to a prefixed calendar, to the above
mentioned gradual revision of the sectoral legislations. In section B-IV we can see that
different GMO products used as food and feed have been already approved by
implementing, exclusively, Regulation (EC) Nº 258/97 (food) or Regulation (EC) Nº
1829/2003 (food and feed).
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Nevertheless, this EU strategy for the development of the GMO’s regulation,
suffered its initial fissures in 1996 when big shipment of GM soya bean arrived to the
European harbours eliciting the first anti-GMO campaign (which foretold irreparable
damages for the environment and the public health), and eventually crumbled from the
moment that some food safety crisis (specially “mad cows”) broke out in the EU and a
much more aggressive media campaign (really well designed but plenty of manicheism
–see B-VIIa- ) was launched comparing the use of the GMO products to these food
crisis (I remember, still astonished, an ecologist lecturer comparing, without any
precision, GMOs to: EXXON VALDEZ shipwreck, Bhopal disaster, Chile and
Argentina dictatorships, etc.).
These anti-GMO groups used the ecology (whose aim, according to its
apologists, is to save the planet) as the integrating element in their battle against all
genetically modified organisms which, also according to these groups opinion, “will
only contribute to the planet destruction” (the same planet, I think).
Reaching this point I cannot resist to draw your attention to the fact, easily
contrastable, that along the history of the world, the detractors of any technological
advance, always needed to be kept grouped under the protected cover of an idea or
philosophy that confers to their “fight” a certain spiritual character. Even today, as you
know, against Darwinism “The Godspell” is brandish (“Genetic modification of crops is
taking mankind into realms that belong to God, and God alone” said recently one of the
world most famous ecologist: H.R.H. the Prince of Wales).
However, in my opinion this aggressive campaign of the ecologists (and
especially of the organic farming producers) against the GMOs is not exempt of a much
more “worldly” component: Economy.
To obtain a bigger economic benefit for their organic products (which are
usually, don’t forget it, more expensive than “conventional” products), organic farming
producers need a reluctant attitude to GMO products by the consumers. This rejection
attitude, on the other hand, will “make easy” for politicians to take the decision of
clearly betting against GMOs once they have come to the conclusion that it is the option
that will bring them more votes.
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In any case, let’s hope that ecologist groups don’t end up identifying
biotechnology as a “bourgeois pseudo science”, as genetics was identified by the
Russian agronomist Trofim D. Lysenko who, during the Stalinist period, promoted and
put into practice some “peculiar” agronomical theories of Lamarckian approach (with
the approval of the political authorities of the epoch who adored the anti capitalist
rhetoric hidden in these theories) that ended up in terrible famines and, even worse, in
the political repression and execution of hundreds of scientists including Nikolai
Vavilov (maybe the most important biologist of the country) who is considered as the
“father” of the Russian genetics.
Well, returning to the sequence of events in the framework of the GMO
regulation in the EU, it seems to be evident that as a consequence of the aggressive antiGMO media campaign above mentioned, a majority of citizens of the EU has a negative
perception of them. This situation has, of course, an immediate political answer (in my
opinion motivated, I insist, for the peculiar “precautionary principle” that moves any
politician to address his actions just in the direction which allows him to maintain the
power). To this end the political answer was, as you know, the establishment in 1998 of
a “de facto moratorium” (“non de iure”) which blocked the approval of new GMOs in
the EU.
The main GMO producing countries (USA, Argentina and Canada) brought the
case to the World Trade Organisation (WTO) which ruled that the EU moratorium was
not based on scientific criteria and consequently was illegal because had broken
international trade rules.
In 2004 the EU was “forced” to lift the moratorium and since then some new
GMO products have been approved. Nevertheless, it looks like GMOs will continue to
be politically ballasted in the near future.
For instance, the decision of some EU Member States governments (France,
Austria, Italia, etc.) to prohibit the cultivation in their territories of the GMO maize
MON810 undermines, in my opinion of course, the prestige and the technical and
scientific credibility of European Food Safety Authority –EFSA- (created, don’t forget,
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“..to guarantee a high level of food safety..”) as well as the confidence of the EU
consumers in future EFSA opinions or advises. What credibility will give the EU
consumers to any future decision of EFSA related to food or environmental safety in
relation with: for instance a possible “avian flu” crisis?.
If you have had courage enough to reach this point of the text, I think you will
be asking yourself if the author of this document has also a personal opinion about the
actions and strategy in this contention of the “other band” (those in favour of GMOs).
Well, first of all I must say that I totally agree, in general, with FAO appraisal
when it says: “Developing countries may gain especially high rewards from new
technologies” (FAO,2002), as well as when it adds: “The dominance of the private
sector in agricultural biotechnology raises concerns that farmers in developing
countries, particularly poor farmers, may not benefit….Private-sector research
focuses on the crops and traits of commercial interest to farmers in higher income
countries where markets for agricultural inputs are robust and profitable.”.
On the other hand I find questionable that the “other band” expressed their
opinions, nearly exclusively, in symposiums and publications (both printed or digital)
totally financed by the main corporations of the sector and where is not unusual to find
really well known researchers and scientists collaborations saying, without any
precision, that GMOs will eradicate world’s famine (!!!).
In this context, any statement made by politicians, scientists, members of the
biotechnological corporations or simple citizens, any news or legal measure in relation
with GMOs, are immediately hailed or tartly reviled by one or another “band”
depending if the statement, news or legal measures are in accordance, or not, with their
respective (and invariable) position on the item.
In my opinion the sector pro-GMOs (mainly the biotechnology industry) would
try to find simple and coherent ideas to convince European consumers. In this respect I
totally agree with the following opinion of an eminent sociologist: “In the USA the
great biotechnological corporations concentrated their strategy in convince the
political power because their opinions and judgments are generally accepted by the
8
citizens. In Europe to convince, first and foremost, the European citizens should have
been the main priority of great biotechnological corporations because European
politicians would not take a decision until citizens had been previously convinced.”
List of GMO legal acts (commented)
A.- International Treaties and Conventions
In my opinion the majority of these International Treaties and Conventions are usually
a compendium of good and ambitious purposes which practically all political leaders in
the world hurry up to sign even thought some of their objectives are not at all easy to
reach due, curiously, to political indolence. The Convention on Biological Diversity,
for instance, recognized that “….social development and poverty eradication are the
first and overriding priorities of developing countries”, but unfortunately, eradication
of poverty and hunger is basically an economic and political (still unsolved) problem as
FAO recognizes in The State of Food and Agriculture-2004 report. Nevertheless, it is
necessary to recognize that these International Treaties and Conventions are, at least, a
first step in the right direction.
A.I.- International Treaties and Conventions
A.I.1.- Convention on Biological Diversity. Promotes “the conservation of biological
diversity, the sustainable use of its components and the fair and equitable sharing of
the benefits arising out of the utilization of genetic resources” . Came into force in
December, 29, 1993.
A.I.2.- Rio Declaration on Environment and Development. It was adopted in the
frame of June 1992 Rio de Janeiro United Nations Conference on Environment and
Development, and includes the “Precautionary approach” concept.
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A.I.3.- Cartagena Protocol on Biosafety to the Convention on Biological
Biodiversity. The objective of the Protocol is to contribute to, in accordance with the
“Precautionary approach” commented in the previous paragraph, “ensuring an
adequate level of protection in the field of the safe transfer, handling and use of
living modified organism resulting from modern biotechnology that may have adverse
effects on the conservation and sustainable use of biological diversity, taking into
account risks to human health, and specifically focusing on transboundary
movements.
A.I.4.- International Treaty on Plant Genetic Resources for Food and Agriculture.
The objective of this Treaty, in harmony with Convention on Biological Diversity, is the
“conservation and sustainable use of plant genetic resources for food and agriculture
and the fair and equitable sharing of the benefits arising out of their use”
A.I.5.- International Plant Protection Convention. This International Convention
was approved in the frame of the International Union for the Protection of New
Varieties of Plants (UPOV). On the necessity to protect new plant varieties breeders
rights, let me to include a textual quotation of Dr. Garcia Olmedo (a relevant Spanish
professor and researcher): “The economic investment, research and creativity behind
a new plant variety of better quality or more productive than those already on the
market needs to be protected. New commercial innovations will not be produced if
this activity is not encouraged by any means. The industry has two alternatives to
profit of its investment: the secret or the legal property protection. The second option
is the only one which offers transparent information.”
A.II.- Community Legal Acts related to International Treaties and Conventions
A,II.1.- Council Decision 2002/628/EC of 25 June, concerning the conclusion, on
behalf of the European Community, of the Cartagena Protocol on Biosafety. By way of
this Regulation the Cartagena Protocol on Biosafety is approved on behalf of the
European Community. In its Annex B, the EC declares itself competent for
10
implementing the obligations resulting there from: preserving, protecting and
improving the quality of the environment, protecting human health and prudent and
rational utilisation of natural resources.
A.II.2.-
Regulation (EC)
Nº 1946/2003 of the European Parliament and the
Council of 15 July, on transboundary movements of genetically modified organisms. By
way of this Regulation a harmonised system of information and notification as well as
the appropriate legal and administrative measures are incorporated to the EU legal
framework to implement all provisions and obligations established by the Cartagena
Protocol.
A.II.3.- Council Decision 2004/869/EC of 24 February, concerning the conclusion, on
behalf of the European Community, of the International Treaty of the Plant Genetic
Resources for Food and Agriculture. The International Treaty of the Plant Genetic
Resources for Food and Agriculture was adopted by the FAO Conference as its 31st
Session in November 2001. By way of this Decision the Treaty is approved on behalf of
the Community.
A.II.4.- Council Decision 2005/523/EC of 30 May, approving the accession of the
European Community for the Protection of New Varieties of Plants, as revised at
Geneva on 19 March 1991. The revised text of the UPOV convention is approved on
behalf of the Community by way of this Decision.
B.- European Union Legislation
B.I.- General legislation
B.I.1.- Directive 98/44/EC of the European Parliament and the Council of 6 June,
on the legal protection of biotechnological inventions. In order to protect
11
biotechnological inventions, this Directive lays down a harmonised set of provisions
related to patentability, licensing, etc.
B.I.2.- Council Decision 1999/468/EC of 28 June, laying down the procedures for the
exercise of implementing powers conferred on the Commission. It provides the basic
elements of Community decision procedure (“Comitology”) see B.III.17., B.V.22. and
B.VIIc)5..
B.I.3.- Commission Decision 2000/443/EC of 18 May, amending Decision 97/404/EC
setting up a Scientific Steering Committee and Decision 97/579/EC setting up
committees in the area of the consumer health and food safety. Provisions related with
the duration of the mandates and confidentiality obligations of the members of
Committees are established by this Decision.
B.I.4.- Commission Regulation (EC) Nº 65/2004 of 14 January, establishing a system
for the development and assignment of unique identifiers for genetically modified
organisms. Unique identifiers are fundamental tools for the traceability of GMO
products. However, GMO medicinal products for human and veterinarian use are not
under the scope of this Regulation (see B.VIIb).2).
B.I.5.- Directive 2004/35/EC of the European Parliament and the Council of 21
April, on environmental liability with regard to the prevention and remedying of
environmental damage. Its Annex III listed the occupational activities under the scope
of this Directive in relation with (possible) environmental damage, for instance
occupational activities with: carbon monoxide, nitric acid, cyanhydric acid, biocides
and………¡¡¡GMOs!!!.
B.I.6.- Council Decision 2006/512/EC: of 17 July 2006 amending Decision
1999/468/EC laying down the procedures for the exercise of implementing powers
conferred on the Commission. Modified Council Decision 1999/468/EC introducing a
new procedure (“Regulatory procedure with scrutiny”) which allows the legislator to
oppose the adoption of draft measures where it indicates that the draft exceeds the
implementing powers provided for in the basic instrument, or that the draft is
12
incompatible with the aim or the content of that instrument or fails to respect the
principles of subsidiarity or proportionality.
B.II.- Contained use of GMMs legislation
B.II.1.- Directive 2009/41/EC of the European Parliament and of the Council of 6
May 2009 on the contained use of genetically modified micro-organisms. This new
Directive recast (“codified”) the Directive 90/219/EEC and the different legal acts
which updated it.
B.III.- Deliberate release of GMOs legislation
B.III.1.- Directive 2001/18/EC of the European Parliament and the Council of 12
May, on the deliberate release into the environment of genetically modified organisms
and repealing Council Directive 90/220/EEC. It replaced, and repealed, Directive
90/220/EEC introducing additional provisions and relevant modifications into the legal
framework of the GMOs regulation in the EU, especially in relation with those
technical aspects more questioned: for instance antibiotic-resistant genes. As you know
this Directive exclusively regulates “living” GMOs (only products “consisting” or
“containing” a GMO). Products “produced from” a GMO are not under the scope of
this Directive.
B.III.2.- Commission Decision 2002/623/EC of 24 July, establishing guidance notes
supplementing Annex II to Directive 2001/18/EC of the European Parliament and the
Council on the deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC. It provides a set of additional
guidance notes on the objectives, elements, general principles and methodology to
conduct the “Environmental Risk Assessment”
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B.III.3.- Council Decision 2002/811/EC of 3 October, establishing guidance notes
supplementing Annex VII of the Directive 2001/18/EC of the European Parliament and
the Council on the deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC. It provides a set of guidance
notes to harmonise the objectives, general principles and design of the plan of
monitoring of GMOs approved.
B.III.4.- Council Decision 2002/812/EC of 3 October, establishing pursuant to
Directive 2001/18/EC of the European Parliament and the Council the summary
information format relating to the placing on the market of genetically modified
organism as or in products. This Decision established a harmonised format to present
the summary information required for the placing on the market of a GMO or a
combination of GMOs as or in products.
B.III.5.- Council Decision 2002/813/EC of 3 October, establishing pursuant Directive
2001/18/EC of the European Parliament and the Council the summary notification
information format for notifications concerning the deliberate release into the
environment of genetically modified organisms for purposes other than placing in the
market. This Decision established a harmonised format to present the summary
information for notifications concerning the deliberate release into the environment of
GMOs for purposes other than placing in the market.
B.III.6.- Commission Decision 2003/653/EC of 2 September, relating to national
provisions on banning the use of genetically modified organisms in the region of Upper
Austria pursuant to Article 95(5) of the EC Treaty. On February 2003 the Upper
Austria region notified the EC of a draft of legal Act banning the use of GMOs on the
region according to the conclusions of a scientific report (“The Müller Study”) which
was attached to the notification. The EC submitted the complete dossier to EFSA. In
July 2003 EFSA concludes that: “…the scientific information presented in the report
provided no new data that would invalidate the provisions for the environmental risk
assessment establish under Directive 90/220/EEC or Directive 2001/18/EC” and
“….no new scientific evidence, in terms of risk to human health and the environment,
that would justify a general prohibition of cultivation of GMOs…..” consequently, by
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way of this Decision the EC reject the national provisions on banning the use of GMOs
in Upper Austria notified by Austria.
B.III.7.- Commission Decision 2003/701/EC of 29 September, establishing pursuant to
Directive 2001/18/EC of the European Parliament and the Council, a format for
presenting the result of the deliberate release into the environment of genetically
modified higher plants other than placing on the market. This Decision established a
harmonised format to present the result of the deliberate release into the environment of
genetically modified higher plants (GMHP) other than placing on the market pursuant
Article 10 of mentioned Directive.
B.III.8.- Commission Decision 2004/204/EC of 23 February, laying down detailed
arrangements for the operation of the registers for recording information on genetic
modifications of GMOs, provided for in Directive 2001/18/EC of the European
Parliament and of the Council. Data and information that shall be included in the
different “registers” are clearly detailed in this Decision. This information should
include, where appropriate, a sample of the GMO, as well as details of nucleotide
sequences and methodology for detecting and identifying the GMO product.
B.III.9.- Commission Decision 2006/10 EC of 10 January, concerning the provisional
prohibition in Greece of the marketing of seeds of maize hybrids with the genetic
modification MON 810 inscribed in the common catalogue of varieties of agricultural
plant species, pursuant to Directive 2002/53/EC. The EC does not authorised Greece to
prohibit in its territory the marketing of seeds of GMO maize (MON810) varieties duly
listed in the EU Common Catalogue of varieties of agricultural plant species.
B.III.10.- Commission Decision 2006/255/EC of 14 March, concerning national
provisions imposing on supermarkets an obligation to place genetically modified food
on separate shelves from non-genetically modified food, notified by Cyprus pursuant to
Article 95(5) of the EC Treaty. The EC declares non-admissible the draft of legal Act
notified by Cyprus seeking to impose on supermarkets an obligation to place GM foods
in a place specially designated for them on separate shelves from non-GM goods.
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B.III.11.- Commission Decision 2006/335/EC of 8 may, authorising the Republic of
Poland to prohibit on its territory the use of 16 genetically modified varieties of maize
with the genetic modification MON 810 listed in the Common catalogue of varieties of
agricultural plant species, pursuant to Council Directive 2002/53/EC. In my opinion the
EC acceptance of the Republic of Poland request to prohibit the use in its territory of 16
GMO maize varieties duly listed in the Common Catalogue of varieties of agricultural
plant species, could be justified on the ground that they are not suitable (similarly to
many other non-GMO varieties also in the Common Catalogue) because of their too
high maturity class which is at least 350 of FAO index of equivalent maturity class.
B.III.12.- Commission Decision 2006/578/EC of 23 August, on emergency measures
regarding the non-authorised genetically modified organism LL RICE 601 in rice
products. The Decision established the conditions for first placing in the EU marked of
a given list of rice products. This emergency measures were (provisionally) taken after
the US authorities informed the EC the presence in the EU of rice products
“contaminated” with non-authorised GM rice trait “LL RICE 601”.
B.III.13.- Commission Decision 2006/601/EC of 5 September, on emergency
measures regarding the non-authorised genetically modified organism LL RICE 601 in
rice products. This Decision confirms the provisional emergency measures regarding
the non-authorised GM rice LL RICE 601. Consequently, it replaces and repealed
Decision 2006/578/EC commented in the preceding paragraph.
B.III.14.- Commission Decision 2006/754/EC of 6 November, amending Decision
2006/601/EC on emergency measures regarding the non-authorised genetically
modified organism LL RICE 601 in rice products. Amended and improve some of the
conditions and control measures laid down by other Decisions dealing with this item
already commented in previous paragraphs: see B.III.12. and B.III.13.
B.III.15.- Commission Decision 2008/62/EC of 12 October 2007, relating to Articles
111 and 172 of the Polish Draft Act on Genetically Modified Organisms, notified by the
Republic of Poland pursuant to Article 95(5) of the EC Treaty as derogations from
provisions of Directive 201/18/EC of the European Parliament and of the Council on the
deliberate release into the environment of genetically modified organisms. The
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Commission stated that two articles of the notified Polish Draft Legal Act on GMOs are
not in accordance with the EU legal framework on GMOs and consequently rejected
them.
B.III.16.- Commission Decision 2008/162/EC of 26 February, amending Decision
2006/601/EC on emergency measures regarding the non-authorised genetically
modified organism LL RICE 601 in rice products. It amended some provisions
established by Decision 2006/601/EC. The date of its new renewal is modified as well
(see B.III.14.).
B.III.17.- Directive 2008/27/EC of the European Parliament and of the Council of
11 March, amending Directive 201/18/EC of the European Parliament and of the
Council on the deliberate release into the environment of genetically modified
organisms as regards the implementing powers conferred on the Commission. The
Council Decision 1999/468/EC lays down the procedures for the exercise of
implementing powers conferred by the Commission. By way of the Council Decision
2006/512/EC a new procedure was introduced (“Regulatory procedure with scrutiny”)
which allows the legislator to oppose the adoption of draft measures where it indicates
that the draft exceeds the implementing powers provided for in the basic instrument, or
that the draft is incompatible with the aim or the content of that instrument or fails to
respect the principles of subsidiarity or proportionality.
The Council Directive 2001/18/EC of the European Parliament and the Council is
accordingly amended by the Directive now commented, in order to adapt it to the new
implementation approach.
B.III.18.- Commission Decision 2008/289/EC of 3 April, on emergency measures
regarding the unauthorised genetically modified organism “Bt 63” in rice products. In
September 2006, rice products originating from China and “contaminated” with the
unauthorised GM rice “Bt 63”, were discovered in the UK, F and D. By way of this
Decision the EC set up a group of control measures of different sensible products,
originating in or consigned, from China into de EC: rice in the husk, milled rice, rice
flour, pasta, different food products obtained from rice, etc..
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B.III.19.- Comisión Decisión 2008/470/EC of 7 May, concerning the prohibition of the
use and sale in Austria of genetically modified maize (Zea mays L. Line T25) pursuant
to Directive 2001/18/EC of the European Parliament and of the Council. The EC
prevents Austria to use in a canning way, once again, the “safeguard clause” to
prohibit in its territory a GM maize (line T25) duly approved in the EU.
B.III.20.- Commission Decision 2009/770/EC of 13 October, establishing standard
reporting formats for presenting the monitoring results of the deliberate release into the
environment of genetically modified organisms, as or in products, for the purpose of
placing on the market, pursuant to Directive 2001/18/EC of the European Parliament
and of the Council. Supplementing the set of guidance notes addressed to harmonize the
objectives, general principles and design of the GMOs Monitoring Plan establish by
Annex VII of Directive 2001/18/EC provided by Decision 2002/811/EC, the Decision
now commented establish harmonized formats for the presentation of monitoring
results, with a particular focus on genetically modified higher plants.
B.III.21.- Commission Decision 2009/828/EC of 3 November, relating to the draft
Regional Legislative Decree declaring the Autonomous Region of Madeira to be an
Area Free of Genetically Modified Organisms, notified by the Republic of Portugal
pursuant to Article 95(5) of the EC Treaty. By way of this Decision the period to
approve or reject the draft Regional Legislative Decree declaring the Autonomous
Region of Madeira to be an Area Free of GMOs, notified by the Republic of Portugal, is
extended to 4 May 2010.
B.IV.- GMOs authorisation Decisions
I think that some of the personal comments in relation with the Decisions of approval of
GMOs (events) included in this Section will help, I hope so, to understand the
regulatory approach: “One door, one key”.
B.IV.1.- Commission Decision 93/572/EEC of 19 October, concerning the placing on
the market of a product containing genetically modified organisms pursuant to Article
18
13 of Council Directive 90/220/EEC. The GMO product approved was an oral antirabies vaccine for foxes.
B.IV.2.- Commission Decision 94/385/EC of 8 June, concerning the placing on the
market of a product consisting of a genetically modified organism, seed oh herbicide
resistant tobacco variety ITB 1000 OX, pursuant to Article 13 of Council Directive
90/220/EEC.
B.IV.3.- Commission Decision 94/505/EC of 18 July, amending the Decision of 18
December 1992 concerning the placing on the market of a GMO product, the vaccine
Nobi.Porvac Aujeszky live (gl, tk) pursuant Article 13 of Council Directive
90/220/EEC. This vaccine for intra-muscular application was approved on December
1992 (the first GMO authorisation in the EU). Accordingly to the approval procedure
provided in Article 13 of Directive 90/220/EEC and in the absence of any objection
from another Member State, the approval decision was given by the Member State that
received and evaluated the application (Germany). Consequently, no formal
“Commission Decision” (similar to this one) was published.
Later on, a further notification was received also by Germany from the same notifier,
requesting to extend the use of the vaccine to intra-dermal applications. In this occasion
a Member State raised an objection to the application. Therefore and accordingly again
with the already mention Article 13, now it was necessary this approval Commission
Decision.
B.IV.4.- Commission Decision 96/158/EC of 6 February, concerning the placing on
the market of a product consisting of a genetically modified organism, hybrid herbicidetolerant swede-rape seeds (Brassica napus L. oleífera Metzq. MS1Bn x RF1Bn)
pursuant to Article 13 of Council Directive 90/220/EEC. The authorisation only covers
the use of the product for growing for obtaining seed but does not extend for uses for
food and feed. Later on, the uses for food and feed were approved by way of Decision
97/392/EC (see B.IV.8, and B.IV.26.-)
B.IV.5.- Commission Decision 96/281/EC of 3 April, concerning the placing on the
market a genetically modified soya beans (Glycine max L.) with increased tolerance to
19
the herbicide glyphosate, pursuant to Council Directive 90/220/EEC. Authorised import
and processing. Not sowing.
B.IV.6.- Commission Decision 96/424/EC of 20 May, concerning the placing on the
market of genetically modified male sterile chicory (Cichorium intybus L.) with partial
tolerance to the herbicide glufosinate ammonium pursuant to Council Directive
90/220/EEC. The authorisation covers the use of the product for breeding activities but
does not extend for uses for food and feed.
B.IV.7.- Commission Decision 97/98/EC of 23 January, concerning the placing on the
market of genetically modified maize (Zea mays L.) with the combine modification for
insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the
herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC.The
authorisation covers all uses: sowing, food, feed….(See B.IV.25).
B.IV.8.- Commission Decision 97/392/EC of 6 June, concerning the placing on the
market of genetically modified swede-rape (Brassica napus L. oleifera Metzg.
MS1xRF1), pursuant to Council Directive 90/220/EEC. The authorisation covers the
growing and handling and processing to non-viable fractions and uses as food and feed,
additionally to those already approved by Decision 92/152/EC (See B.IV.26).
B.IV.9.- Commission Decision 97/393/EC of 6 June, concerning the placing on the
market of genetically modified swede-rape (Brassica napus L. oleifera Metzg.
MS1xRF2), pursuant to Council Directive 90/220/EEC. The authorisation covers the
growing and handling and processing to non-viable fractions. (See B.IV.27)
B.IV.10.- Commission Decision 97/549/EC of 14 July, concerning the placing on the
market of T102-test (Streptococcus thermophilus T102) pursuant to Council Directive
90/220/EEC. The product approved was a test for the detection of antibiotics residues
in milk.
B.IV.11.- Commission Decision 98/291/EC of 22 April, concerning the placing on the
market of genetically modified spring swede-rape (Brassica napus L. ssp. oleifera)
20
pursuant to Council Directive 90/220/EEC. Authorised import and processing. Not
sowing (See B.IV.28).
B.IV.12.- Commission Decision 98/292/EC of 22 April, concerning the placing on the
market of genetically modified maize (Zea mays L. Line Bt-11) pursuant to Council
Directive 90/220/EEC. Authorised import and processing. Not sowing.
B.IV.13.- Commission Decision 98/293/EC of 22 April, concerning the placing on the
market of genetically modified maize (Zea mays T25) pursuant to Council Directive
90/220/EEC. The authorisation covers all uses: sowing, food, feed…..
B.IV.14.- Commission Decision 98/294/EC of 22 April, concerning the placing on the
market of a genetically modified maize (Zea mays L. line MON 810) pursuant to
Council Directive 90/220/EEC. The authorisation covers all uses: sowing, food, feed…..
B.IV.15.- Commission Decision 2004/643/EC of 19 July, concerning the placing on
the market, in accordance with Directive 2001/18/EC of the European Parliament and
the Council, of a maize product (Zea mays L. line NK603) genetically modify for
glyphosate tolerance. The authorisation excluded sowing and use as or in food. By way
of Decision 2005/448/EC (see B.IV.17) uses of this GMO as food and food ingredients
was approved.
B.IV.16.- Commission Decision 2005/448/EC of 3 March, authorising the placing on
the market of food and food ingredients derived from genetically modified maize line
NK 603 as novel food or food ingredients under Regulation (EC) Nº 258/97 of the
European Parliament and the Council. (See B.IV.15)
B.IV.17.- Commission Decision 2005/608/EC of 8 August, concerning the placing on
the market, in accordance with Directive 2001/18/Ec of the European Parliament and of
the Council, of a maize product (Zea mays L. line MON 863) genetically modify for
resistance to corn rootworm. The authorisation excluded sowing and use as or in food.
By way of Decision 2006/68/EC (see B.IV.22) uses of this GMO as food and food
ingredients were approved.
21
B.IV.18.- Commission Decision 2005/635/EC of 31 August, concerning the placing on
the market, in accordance with Directive 2001/18/EC of the European Parliament and
the Council, of an oilseed rape product (Brassica napus line GT 73) genetically
modified for tolerance to the herbicide glyphosate. The authorisation excluded sowing
and use as or in food.
B.IV.19.- Commission Recommendation 2005/637/EC of 16 August, concerning the
measures to be taken by the consent holder to prevent any damage to health and
environment in the event of an accident spillage of an oilseed rape (Brassica napus line
GT 73) genetically modified for tolerance to the herbicide glyphosate. Provide a set of
measures addressed to prevent any damage to health and the environment in case of
accidental spillage of this product in port facilities.
B.IV.20.- Commission Decision 2005/772/EC of 3 November, concerning the placing
on the market, in accordance with Directive 2001/18/EC of the European Parliament
and the Council, of a maize product (Zea mays L. line 1507) genetically modify for
resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinateammonium. The authorisation excluded sowing and use as or in food. By way of
Decision 2006/197/EC (see B.IV.23) uses of this GMO as food and food ingredients
was approved.
B.IV.21.- Commission Decision 2006/47/EC of 16 January, concerning the placing on
the market, in accordance with Directive 2001/18/EC of the European Parliament and
the Council, of a maize product (Zea mays L. hybrid MON 863 x MON 810) genetically
modified to resistance to corn rootworm and certain lepidopteran pests of maize. The
authorisation excluded sowing and use as or in food and feed. At the moment only
import and processed products are approved.
B.IV.22.- Commission Decision 2006/68/EC of 13 January, authorising the placing on
the market of food and food ingredients derived from genetically modified maize line
MON 863 as a novel food or novel food ingredients under Regulation (EC) Nº 258/97
of the European Parliament and of the Council. (See B.IV.17)
22
B.IV.23.- Commission Decision 2006/197/EC of 3 March, authorising the placing on
the market of food containing, consisting of or produced from genetically modified
maize line 1507 (DAS-01507-1) pursuant to Regulation Nº 1829/2003 of the European
Parliament and of the Council. (See B.IV.20). Modified by Decision 2011/365/EU
B.IV.24.- Commission Decision 2007/232/EC of 26 March, concerning the placing on
the market, in accordance with Directive 2001/18/EC of the European Parliament and of
the Council, of oilseed rape products (Brassica napus L. lines Ms8, Rf3 and Ms8xRf3)
genetically modify for tolerance to the herbicide glufosinate-ammonium. The
authorisation excluded sowing and use as or in food. However, processed oil derived
from this oilseed rape was approved for placing in the market in 1999 according to
Article 5 of Regulation (EC) Nº 258/97 (“substantial equivalence” see B.V.4).
B.IV.25.- Commission Decision 2007/304/EC of 25 April, on the withdrawal from the
market of Bt176 (SYN-EV176-9) maize and its derived products. The authorisation for
placing in the market is not renewed by the notifier because it has stopped selling seed
in the EU. Therefore, neither the cultivation nor the placing on the market on any
product containing, consisting or produced from this “event” were authorised in the
Community after 18 April 2007. Some provisions are additionally laid down for its
(possible) adventitious or technically unavoidable presence during the next 5 years.
Decision 97/98/EC, however, is not repealed.
B.IV.26.- Commission Decision 2007/305/EC of 25 April, on the withdrawal from the
market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its
derived products. The authorisation for placing in the market is not renewed by the
notifier because it has stopped selling varieties containing this event on a global basis.
Therefore, the placing on the market of neither this GM oilseed rape nor any product
produced or derived from this “event” (even the oil approved according to article 5 of
Regulation EC Nº 258/97) were authorised in the Community after 18 April 2007. Some
provisions are additionally laid down for its (possible) adventitious or technically
unavoidable presence during the next 5 years.
Decision 96/158/EC and Decision
97/392/EC, however, are not repealed.
23
B.IV.27.- Commission Decision 2007/306/EC of 25 April, on the withdrawal from the
market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its
derived product. The authorisation for placing in the market is not renewed by the
notifier because it has stopped selling varieties containing this event on a global basis.
Therefore, the placing on the market of neither this GM oilseed rape nor any product
produced or derived from this “event” (even the oil approved according to article 5 of
Regulation EC Nº 258/97) were authorised in the Community after 18 April 2007. Some
provisions are additionally laid down for its (possible) adventitious or technically
unavoidable presence during the next 5 years. Decision 97/393/EC, however, is not
repealed.
B.IV.28.- Commission Decision 2007/307/EC of 25 April, on the withdrawal from the
market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products. The
authorisation for placing in the market is not renewed by the notifier because it has
stopped selling varieties containing this event on a global basis. Therefore, the placing
on the market of neither this GM oilseed rape nor any product produced or derived
from this “event” (even the oil approved according to article 5 of Regulation EC Nº
258/97) were authorised in the Community after 18 April 2007. Some provisions are
additionally laid down for its (possible) adventitious or technically unavoidable
presence during the next 5 years. Decision 98/291/EC, however, is not repealed.
B.IV.29.- Commission Decision 2007/308/EC of 25 April, on the withdrawal from the
market of products derived from GA21x MON810 (MON-ØØØ21-9xMONØØ81Ø-6)
maize. I am totally confused, I must confess, with this specific Decision. Food and Feed
additives produced from this event were notified, in accordance to Article 8 of
Regulation (EC) Nº 1829/2003 as “existing products” in the EU. They were approved
(apparently in 1998) under Directive 89/107/EEC (food additives) and 70/524/EEC
(feed additives see B.V.8). I know that by way of Directive 93/114/EC, the Directive
70/524/EEC was provided with an environmental risk assessment analogous to that
established in Directive 90/220/EEC but, as far as I know, Directive 89/107/EEC does
not include a single reference to (possible) GMO food additives. My question is: was
the placing on the market (previously to 18 March 2004: date of applicability of
Regulation (EC) Nº 1829/2003) of this food and feed additives derived from
GA21xMON810 maize approved in the framework of GMO regulation?. Anyway, the
24
Decision now commented informed us that the notifier has stopped selling varieties
containing this event on a global basis, and consequently, de Decision stated that
products derived from the above mentioned GM “…cannot be placed on the market in
the Community after 18 April 2007”. But surprisingly and in clear contradiction with
the previous statement, the Decision informed also to us that, during next 5 years, a
presence (adventitious or technically unavoidable) of a 0,9 of material produced from
this event in food and feed will be tolerated (?).
B.IV.30.- Commission Decision 2007/364/EC of 23 May, concerning the placing on
the market, in accordance with Directive 2001/18/EC of the European Parliament and
the Council, of a carnation (Dianthus caryophylus L. line 123.2.38) genetically
modified for flower colour. The product approved was GM cut flowers only to
ornamental use. Cultivation is not authorised.
B.IV.31.- Commission Decision 2007/692/EC of 24 October, authorising the placing
on the market of food and feed produced from genetically modified sugarbeet H7-1
(KM-ØØØH71-4) pursuant to Regulation (EC) Nº 1829/2003 of the European
Parliament and of the Council..
B.IV.32.- Commission Decision 2007/701/EC of 24 October, authorising the placing
on the market of products containing, consisting of and produced from genetically
modified maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to
Regulation 1829/2003 of the European Parliament and of the Council. Food and feed
products consisting, containing or produced from this GM maize are approved by way
of this Decision. Cultivation is excluded from the authorisation.
B.IV.33.- Commission Decision 2007/702/EC of 24 October, authorising the placing
on the market of products containing, consisting of and produced from genetically
modified maize 59122 (DAS-59122-7) pursuant to Regulation 1829/2003 of the
European Parliament and of the Council. Food and feed products consisting, containing
or produced from this GM maize are approved by way of this Decision. Cultivation is
excluded from the authorisation.
25
B.IV.34.- Commission Decision 2007/703/EC of 24 October, authorising the placing
on the market of products containing, consisting of and produced from genetically
modified
maize
1507xNK603
(DAS-Ø15Ø7-1xMON-ØØ6Ø3-6)
pursuant
to
Regulation 1829/2003 of the European Parliament and of the Council. Food and feed
products consisting, containing or produced from this GM maize are approved by way
of this Decision. Cultivation is excluded from the authorisation.
B.IV.35.- Commission Decision 2008/279/EC of 28 March, repealing Decision
2006/69/EC authorising the placing on the market of foods and food ingredients
produced from genetically modified Roundup Ready maize line GA21 as novel food
and novel food ingredients under Regulation (EC) nº 258/97 of the European Parliament
and of the Council. By way of Decision 2006/69/EC (now repealed) it was approved, in
accordance to Regulation (EC) Nº 258/97, the placing on the market of food products
“produced from” GM maize GA21. However, food products “containing” or
“consisting” in this GM maize were not included in the approval. Consequently the
grains of the GM maize GA21 were not authorised. See B.IV.36).
B.IV.36.- Commission Decision 2008/280/EC of 28 March, authorising the placing on
the market of products containing, consisting of and produced from genetically
modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation 1829/2003 of the
European Parliament and of the Council. Once the Decision 2006/69 has been repealed
(see B.IV.35), a new notifier submit an application for the authorisation of food and
feed containing, consisting or produced from GM maize GA21 in accordance, in this
occasion, to Regulation (EC) Nº 1829/2003. The application has been approved by way
of this Decision. GM grains are included in the GM products now approved (for food
and feed).
B.IV.37.- Commission Decision 2008/730/EC of 8 September, authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified soybean A2704-12 (ACS-GMǾǾ5-3) pursuant to Regulation (EC) nº
1829/2003 of the European Parliament and of the Council. Food and feed products
consisting, containing or produced from this GM soybean (and products other than food
and feed containing or consisting of this GM soybean) are approved by way of this
Decision. Cultivation is excluded from the authorisation.
26
B.IV.38.- Commission Decision 2008/837/EC of 29 October, Authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) Nº 1829/2003 of
the European Parliament and of the Council. Food and feed products consisting,
containing or produced from this GM cotton (as well as products other than food and
feed for the same uses as any other cotton), are approved by way of this Decision.
Cultivation is excluded from the authorisation.
B.IV.39.-Commission Decision 2008/933/EC of 4 December, authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) Nº
1829/2003 of the European Parliament and of the Council. Food and feed products
consisting, containing or produced from this GM soybean (and products other than food
and feed containing or consisting of this GM soybean) are approved by way of this
Decision. Cultivation is excluded from the authorisation.
B.IV.40.- Commission Decision 2009/184/EC of 10 March, authorising the placing on
the market of products containing or produced from genetically modified oilseed rape
T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third
countries until 2005 pursuant to Regulation (EC) nº 1829/2003 of the European
Parliament and of the Council. This Decision confirm (and increment) my personal
confusion about the EU regulation on “existing products” (notified in accordance to
article 8 of Regulation (EC) 1829/2003 -see B.IV.29.-). According to the provisions
related to “existing products” some food additives and feed materials produced from
T45 oilseed rape were approved. By way of the Commission Decision now commented,
the EC additionally authorise (!!for a 10 years period¡¡) the placing in the market of
foods and feed containing or produced from this oilseed rape (as well as products other
than food and feed containing it) in order “..to cover the presence in products of T45
oilseed rape resulting from the commercialisation of T45 oilseed rape seeds in third
countries..” where, on the other hand, its cultivation stopped ¡¡in 2005!!. Quite
logically, the next step of the EU would be to authorise, by identical reasons, all
products containing or produced from any “event/trait” already authorised (or is about
27
to be authorised) in a third country. But this hypothesis is quite improbable taking into
account the current EC strategy (??) on GMOs regulation.
B.IV.41.- Commission Decision 2009/244/EC concerning the placing on the market, in
accordance with Directive 2001/18/Ec of the European Parliament and of the Council,
of a carnation (Dianthus caryophylus L., line 123.8.12) genetically modified for flower
colour. The product approved was GM cut flowers only to ornamental use. Cultivation
is not authorised.
B.IV.42.- Commission Decision 2009/813/EC of 30 October, authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified maize MON 89034 (MON-89Ø34-3) pursuant to Regulation (EC) Nº
1829/2003 of the European Parliament and of the Council. Food and feed products
consisting, containing or produced from this GM maize (and products other than food
and feed containing or consisting of this GM maize) are approved by way of this
Decision. Cultivation is excluded from the authorisation.
B.IV.43.- Commission Decision 2009/814/EC of 30 October, authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified maize MON 88017 (MON-88Ø17-3) pursuant to Regulation (EC) Nº
1829/2003 of the European Parliament and of the Council. Food and feed products
consisting, containing or produced from this GM maize (and products other than food
and feed containing or consisting of this GM maize) are approved by way of this
Decision. Cultivation is excluded from the authorisation.
B.IV.44.- Commission Decision 2009/815/EC of 30 October, authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified
maize
59122xNK603
(DAS-59122-7xMON-ØØ6Ø3-6)
pursuant
to
Regulation (EC) Nº 1829/2003 of the European Parliament and of the Council. Food
and feed products consisting, containing or produced from this GM maize (and
products other than food and feed containing or consisting of this GM maize) are
approved by way of this Decision. Cultivation is excluded from the authorisation.
28
B.IV.45.- Commission Decision 2009/866/EC of 30 November, authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) Nº 1829/2003 of
the European Parliament and of the Council. Food and feed products consisting,
containing or produced from this GM maize (and products other than food and feed
containing or consisting of this GM maize) are approved by way of this Decision.
Cultivation is excluded from the authorisation.
B.IV.46.- Commission Decision 2010/135/EU of 2 March 2010 concerning the placing
on the market, in accordance with Directive 2001/18/EC of the European Parliament
and of the Council, of a potato product (Solanum tuberosum L. lines EH92-527-1)
genetically modified for enhanced content of the amylopectin component of starch. The
placing on the market for cultivation and industrial uses of this GM potato is approved.
B.IV.47.- Commission Decision 2010/136/EU of 2 March 2010, authorising the
placing on the market of feed produced from genetically modified potato EH92-527-1
(BPS-25271-9) and the adventitious or technically unavoidable presence of the potato in
food and other feed products under Regulation (EC) Nº 1829/2003 of the European
Parliament and of the Council. By way of this Decision, foods and feed with a presence
of this GMO in a proportion no higher than 0,9 % (when the food or feed consist of a
single ingredient) or a 0,9 % per each ingredient are approved, providing that this
GMO presence is adventitious or technically unavoidable.
B.IV.48.- Commission Decision 2010/139/EU of 2 March 2010 authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified
maize
MON863xMON810xNK603
(MON-ØØ863-5xMON-ØØ81Ø-
6xMON-ØØ6Ø3-6) pursuant to Regulation (EC) Nº 1829/2003 of the European
Parliament and of the Council. Food and feed products consisting, containing or
produced from this GM maize (and products other than food and feed containing or
consisting of this GM maize) are approved by way of this Decision. Cultivation is
excluded from the authorisation.
B.IV.49.- Commission Decision 2010/140/EU of 2 March 2010 authorising the placing
on the market of products containing, consisting of, or produced from genetically
29
modified maize MON863xMON810 (MON-ØØ863-5xMON-ØØ81Ø-6) pursuant to
Regulation (EC) Nº 1829/2003 of the European Parliament and of the Council. Food
and feed products consisting, containing or produced from this GM maize (and
products other than food and feed containing or consisting of this GM maize) are
approved by way of this Decision. Cultivation is excluded from the authorisation.
B.IV.50.- Commission Decision 2010/141/EU of 2 March 2010 authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified maize MON863xNK603 (MON-ØØ863-5xMON-ØØ6Ø3-6) pursuant to
Regulation (EC) Nº 1829/2003 of the European Parliament and of the Council. Food
and feed products consisting, containing or produced from this GM maize (and
products other than food and feed containing or consisting of this GM maize) are
approved by way of this Decision. Cultivation is excluded from the authorisation.
B.IV.51.- Commission Decision 2010/419/EU of 28 of July, renewing the
authorisation for continued marketing of products containing, consisting of, or produced
from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food
ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to
Regulation (EC) Nº 1829/2003 of the European Parliament and of the Council and
repealing Decision 2004/657/EC. By way of this Decision are renewed the authorisation
for the marketing of: products consisting, containing or produced from GM sweet corn
containing the event Bt11 (approved by Decision 2004/657/EC); food and food
ingredients derived (consequently “grains” were excluded) from GM maize Bt11
(approved by the Regulation 258/97 on the framework of the “substantially
equivalence” regime -see B.V.4.-). The Decision approved as well the authorisation of
food and food ingredients consistent or containing GM maize Bt11 other than sweet
corn (sweet corn is regulated by Directive 2002/55/EC as long as “other” maize is
regulated by Directive 66/402/EC).
B.IV.52.- Commission Decision 2010/420/EU of 28 of July, authorising the placing on
the market of products containing, consisting of, or produced from genetically modified
maize MON89034xNK603 (MON-89Ø34-3xMON-ØØ6Ø3-6) pursuant to regulation
(EC) Nº 1829/2003 of the European Parliament and of the Council. Food and feed
products consisting, containing or produced from this GM maize (and products other
30
than food and feed containing or consisting of this GM maize) are approved by way of
this Decision. Cultivation is excluded from the authorisation.
B-IV.53.- Commission Decision 2010/426/EU of 28 of July, authorising the placing on
the market of products containing, consisting of, or produced from genetically modified
maize Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9) pursuant to regulation (EC) Nº
1829/2003 of the European Parliament and of the Council. Food and feed products
consisting, containing or produced from this GM maize (and products other than food
and feed containing or consisting of this GM maize) are approved by way of this
Decision. Cultivation is excluded from the authorisation.
B.IV.54.- Commission Decision 2010/428/EU of 28 of July, authorising the placing on
the market of products containing, consisting of, or produced from genetically modified
maize 59122x1507xNK603 (DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6) pursuant to
regulation (EC) Nº 1829/2003 of the European Parliament and of the Council. Food and
feed products consisting, containing or produced from this GM maize (and products
other than food and feed containing or consisting of this GM maize) are approved by
way of this Decision. Cultivation is excluded from the authorisation. (The Official
Journal of the EU of 2nd December 2010, published a Corrigendum to introduce some
text corrections related to the “unique identifier”).
B.IV.55.- Commission Decision 2010/429/EU of 28 of July, authorising the placing on
the market of products containing, consisting of, or produced from genetically modified
maize MON 88017xMON810 (MON-88Ø17-3xMON-ØØ81Ø-6) pursuant to regulation
(EC) Nº 1829/2003 of the European Parliament and of the Council. Food and feed
products consisting, containing or produced from this GM maize (and products other
than food and feed containing or consisting of this GM maize) are approved by way of
this Decision. Cultivation is excluded from the authorisation.
B.IV.56.- Commission Decision 2010/432/EU of 28 of July, authorising the placing on
the market of products containing, consisting of, or produced from genetically modified
maize 1507x59122 (DAS-Ø15Ø7-1xDAS-59122-7) pursuant to regulation (EC) Nº
1829/2003 of the European Parliament and of the Council. Food and feed products
consisting, containing or produced from this GM maize (and products other than food
31
and feed containing or consisting of this GM maize) are approved by way of this
Decision. Cultivation is excluded from the authorisation. (The Official Journal of the
EU of 2nd December 2010, published a Corrigendum to introduce some text corrections
related to the “unique identifier”).
B.IV.57.- Commission Decision 2011/354/EU of 17 June 2011 authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003
of the European Parliament and of the Council. Food and feed products consisting,
containing or produced from this GM maize (and products other than food and feed
containing or consisting of this GM maize) are approved by way of this Decision.
Cultivation is excluded from the authorisation.
B.IV.58.- Commission Decision 2011/365/EU of 17 June 2011 amending Decision
2006/197/EC as regards the renewal of the authorisation to place on the market existing
feed produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to
Regulation (EC) No 1829/2003 of the European Parliament and of the Council.
Decision 2006/197/EC authorised the placing on the market of food and food
ingredients containing or consisting in of GM maize 1507. By way of the Decision now
commented the authorisation of the placing on the market of feed produced from this
GM maize are renewed (this GM feed were authorised, as “existing products”, in
accordance to article 20 of Regulation (EC) nº 1829/2003 (See B.IV.23.-).
B.IV.59.- Commission Decision 2011/366/EU of 17 June 2011 authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified maize MON 89034 × MON 88017 (MON-89Ø34-3xMON-88Ø17-3) pursuant
to Regulation (EC) No 1829/2003 of the European Parliament and of the Council. Food
and feed products consisting, containing or produced from this GM maize (and
products other than food and feed containing or consisting of this GM maize) are
approved by way of this Decision. Cultivation is excluded from the authorisation.
32
B.V.- GM food and feed legislation
Regulation of GM feed in the EU is a peculiar item because the legislation on GM feed
and legislation on GM feed additives has not been developed in parallel. Before the
date of application of Regulation (EC) Nº 1829/2003, the sectoral regulation on feed
includes no requirements to GM feed additional to those applicable to conventional
one. Therefore, feed products “containing or consisting in” (we are referring to
“grains”) GM maize: BT 176 (B.IV.7); Bt 11 (B.IV.12), T 25 (B.IV. 13) and MON 810
(B.IV.14), as well as soya (B-IV-5) and two swede rape (B-IV-8 and B-IV-11): could
be used as feed with no requirement (additional to those applicable to “conventional”
feed) other than their identification as GMO.
On the other hand, as I have already commented in B.IV.29., feed additives legislation
includes an specific requirement for environmental risk assessment (applicable to GM
feed additives) analogous to this established by Directive 90/220/EEC.
B.V.1.- Council Directive 88/388/EEC of 22 June, on approximation of the laws of the
Member States relating to flavourings for use in foodstuffs and to source materials for
their production. It is the basic legal act on this item.
B.V.2.- Council Directive 89/107/EC of 21 December, on the approximation of the
laws of the Member States concerning food additives authorised for use in foodstuffs
used intended for human consumption. Included in the document because it is the basic
legal act on this item.
B.V.3.- Directive 95/2/EC of the European Parliament and of the Council of 20
February, on food additives other than colours and sweeteners. Included in the
document because it is the basic legal act on this item.
B.V.4.- Regulation (EC) Nº 258/97 of the European Parliament and of the Council
of 27 January, concerning novel food and novel food ingredients. In the scope of “novel
food” the following products are included: food and food ingredients “containing”,
33
“consisting of” or produced from GMOs as well as food and food ingredients obtained
by different (non- biotechnological) production processes.
From 18 April 2004 (date of application of Regulation (EC) Nº 1829/2003 –see B.V.6.)
all provisions related to GMOs products of this Regulation were duly repealed
(however, until 2006 -see B.IV.22.-, some GMO food and food ingredients were
approved according to it).
Let me draw your attention to the “peculiar” authorisation procedure provided in
Article 5 of this Regulation (“substantial equivalence”) which, in my opinion,
introduces a certain inconsistency in the GMO global regulation framework.
According to the mentioned procedure (also known as “notification” procedure) the
placing on the market of food and food ingredients produced from (but not containing)
a GMO could be authorised if they are deemed substantially equivalent to existing food
and food ingredients as regards their composition, nutritional value, etc..
Accordingly to this specific procedure food and food ingredients “produced” from flour
of GM maize MON810 were approved as well as oil “derived” from the same GM
maize. Oil “derived” from the GM maize is the final product of an industrial process
and probably no DNA from the GM trait is present in it. On the contrary, as far as I
know, food and food ingredients “produced” from GM maize flour (milled grains)
clearly contains more or less DNA of the GM trait and consequently they can’t be
deemed substantially equivalent in composition to existing (obviously: non-GMO) food
and food ingredients.
In any case, according to this “peculiar” (I insist) procedure different food and food
ingredients (GMO and non-GMO) were approved. Each year a summary of the
“notifications” for placing on the market of these products was published in C series of
the Official Journal. The “notifications” related to a GMO were:
=(1998) OJ C200: notifications numbered 1 to 4
=(1999) OJ C181: notifications numbered 5 to 7
=(2000) OJ C71: notifications numbered 8 to 10
=(2001) OJ C46: notification number 11
=(2003) OJ C33: notification numbered 14 and 15.
34
B.V.5.- Directive 2000/13/EC of the European Parliament and of the Council of 20
March, on the approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs. This Directive codified, and consequently
repealed, Directive 79/112/EEC on the approximation of the laws of the Member States
relating to the labelling, presentation and advertising of foodstuffs for sale to the
ultimate consumer, which is an usual reference on this item in the EU regulation on GM
food, food ingredients as well as GM food additives and flavourings. Will be repealed
on 13 December 2014, date of legal application of Regulation (EU) Nº 1169/2011. See
B.V.30
B.V.6.- Commission Directive 2001/101/EC of 26 November, amending Directive
2000/13/EC of the European Parliament and the Council on the approximation of the
laws of the Member States relating to the labelling, presentation and advertising of
foodstuffs. Directive 2000/13/EC is amended, adding a harmonised and clear definition
of “meat” in order to avoid consumer confusion. See B.V.5
B.V.7.- Regulation (EC) Nº 178/2002 of the European Parliament and of the
Council of 28 January, laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and laying down procedures in
matters of food safety. This Regulation was born as the basic legal tool in order to
obtain in the EU: “..a high level of heath protection as appropriate in the development
of food law..” as well as “..to ensure that consumers….have confidence in the
decision-making processes underpinning food law…”. According to this aim an
European Food Safety Authority is established “..to guarantee a high level of food
safety…”. However, as I have already pointed out in the INTRODUCTION of this
work, the recent French Government decision in relation to MON810 and other
Member States decisions, totally undermine, in my opinion, the value of this Regulation
and consequently of the global GMO legislation in the EU as well.
B.V.8.- Regulation (EC) Nº 1829/2003 of the European Parliament and of the
Council of 22 September, on genetically modified food and feed. It provides a
harmonised authorisation procedure for placing on the market GMO food and feed. In
relation to food, this Regulation replaces (taking into account technical progress and
experience gained along the years) all provisions which, in this respect, were included
35
in Regulation (EC) Nº 258/97 –see B.V.4.-. On the other hand, as you know, no
authorisation procedure exists, so far, for feed produced from GMO (see B.V).
B.V.9.- Regulation (EC) Nº 1830/2003 of the European Parliament and of the
Council of 22 September concerning the traceability and labelling of genetically
modified organisms and the traceability of food and feed products produced from
genetically modified organisms and amending Directive 2001/18/EC. It provides a
harmonised set of requirements for an accurate labelling and traceability of GMOs and
GMOs food and feed products.
B.V.10.- Regulation (EC) Nº 1831/2003 of the European Parliament and of the
Council of 22 September on additives for use in animal nutrition. Review, and repeal,
Council Directive 70/524/EEC concerning additives in feedindstuffs in order to take
into account technological progress and the need to ensure a greater degree of
protection of animal and human heath and of the environment in relation to feed
additives placed on the market. However, GMO feed additives should undergo an
additional authorisation procedure, before they are placed on the market, provided for
by Regulation (EC) 1829/2003 (already commented) because objectives of both
Regulations are different.
B.V.11.- Directive 2003/89/EC of the European Parliament and of the Council of 10
November, amending Directive 2000/13/EC as regards indication of the ingredients
present in foodstuffs. In relation to certain additives, processing aids and other
substances of possible allergenic effect which are usually present in foodstuffs and
beverages, this Directive provides additional identification and labelling requirements
to those provided by Directive 2000/13/EC in order to avoid adverse reactions on
consumers. See B.V.5
B.V.12.- Commission Regulation (EC) Nº 641/2004 of 6 April, on detailed rules for
the implementation of Regulation (EC) Nº 1829/2003 of the European Parliament and
of the Council as regards the application for the authorisation of new genetically
modified food and feed, the notification of existing products and adventitious or
technically unavoidable presence of genetically modified material which has benefited
from a favourable risk evaluation. It provides transitional measures in order to adapt
36
notifications of products falling within the scope of other Community legislation to the
new Regulation (EC) Nº 1829/2003. Detailed rules on the preparation and presentation
of notifications of “existing products” in the EU before the date of application of
Regulation (EC) Nº 1829/2003 are also provided (see B.IV.29).
B.V.13.- Commission Decision 2004/613/EC of 6 August, concerning the creation of
an advisory group on the food chain and animal and plant health. Different Advisory
Committees on maters concerning food chain and animal and plant health are
regrouped and reorganised on the “Advisory Group on food chain and animal and
plant heath”
B.V.14.- Regulation (EC) Nº 882/2004 of the European Parliament and of the
Council of 29 April, on official controls performed to ensure the verification of
compliance with feed and food law, animal health and animal welfare rules. In order to
verify that food and feed in the EU complies with food and feed law (basic rules as well
as more specific food and feed rules) at all stages of production, processing and
distribution, this Regulation establishes a harmonized set of provisions to carry out the
“official control” for the verification of compliance with food and feed law, animal
health and animal welfare rules.
B.V.15.- Commission Recommendation 2004/787//EC of 4 October, on technical
guidance for sampling and detection of genetically modified organisms as or in products
in the context of Regulation (EC) Nº 1830/2003. In order to achieve an appropriate
level of confidence for detection of GMOs or material produced from GMOs, this
Recommendation provide a technical guidance (including general principles and
protocols) for the sampling and detection of GMOs. In relation to sampling of seed, for
instance, ISTA rules will apply.
B.V.16.- Commission Regulation (EC) Nº 2230/2004 of 23 December, laying down
detailed rules for the implementation European Parliament and Council Regulation (EC)
Nº 178/2002 with regard to the network of organisation operating in the fields within
the European Food Safety Authority’s mission. It provides a set of measures to connect
in a scientific as well as financial way, EFSA and national organisations performing
similar tasks.
37
B.V.17.- Commission Regulation (EC) Nº 575/2006 of 7 April, amending Regulation
(EC) Nº 178/2002 of the European Parliament and of the Council as regards the number
and names of the permanent Scientific Panels of the European Food Safety Authority. A
Scientific Panel is renamed and a new one is created.
B.V.18- Regulation (EC) Nº 1924/2006 of the European Parliament and of the
Council of 20 December, on nutrition and health claims made on foods. It provides a
set of conditions to regulate the use of nutrition and health claims in food labels or
advertising.
B.V.19.- Commission Regulation (EC) Nº 1981/2006 of 22 December, on detailed
rules for the implementation of Article 32 of Regulation (EC) Nº 1829/2003 of the
European Parliament and of the Council as regards the Community reference laboratory
for genetically modified organisms. Detailed rules for the implementation of Article 32
of Regulation (EC) Nº 1829/2003 (Community Reference Laboratories) are given. It
sets the list of the Community laboratories and provides the procedure related with
financial contribution to be paid by applicants.
B.V.20.- Regulation (EC) Nº 298/2008 of the European Parliament and of the
Council of 11 March, amending Regulation (EC) Nº 1829/2003 on genetically modified
food and feed, as regards the implementing powers conferred on the Commission. The
Council Decision 1999/468/EC lays down the procedures for the exercise of
implementing powers conferred by the Commission. By way of the Council Decision
2006/512/EC a new procedure was introduced (“Regulatory procedure with scrutiny”)
which allows the legislator to oppose the adoption of draft measures where it indicates
that the draft exceeds the implementing powers provided for in the basic instrument, or
that the draft is incompatible with the aim or the content of that instrument or fails to
respect the principles of subsidiarity or proportionality.
The Regulation (EC) nº 1829/2003 of the European Parliament and the Council is
accordingly amended by the Regulation now commented, in order to adapt it to the new
implementation approach.
38
B.V.21.- Commission Decision 2008/721/EC of 5 August, setting up an advisory
structure of Scientific Committees and experts in the field of consumer safety, public
heath and the environment and repealing Decision 2004/210/EC. By way of the
Commission Decision 2004/210/EC (now repealed) three Scientific Committees were
set up in the field of consumer safety, public health and the environmet namely “SC on
Consumer Products”; “SC on Health and Environmental Risks” and “SC on Emerging
and Newly Identified Health Risks”.
The new Commission Decision, now commented, maintain the three Scientific
Committees (the first one is renamed: “SC on Consumer Safety”) and a pool of
Scientific Advisors on Risk Assessment is established to support the activities of the
Scientific Committees.
B.V.22.- Regulation (EC) Nº 1137/2008 of the European Parliament and of the
Council of 22 October adapting a number of instruments subject to the procedure laid
down in Article 251 of the Treaty to the Council Decision 1999/468/EC, with regard to
the regulatory procedure with scrutiny. The Council Decision 1999/468/EC lays down
the procedures for the exercise of implementing powers conferred by the Commission.
By way of the Council Decision 2006/512/EC a new procedure was introduced
(“Regulatory procedure with scrutiny”) which allows the legislator to oppose the
adoption of draft measures where it indicates that the draft exceeds the implementing
powers provided for in the basic instrument, or that the draft is incompatible with the
aim or the content of that instrument or fails to respect the principles of subsidiarity or
proportionality.
By way of the Regulation now commented, several legal acts regulating different EU
technical areas are reviewed in order to adapt them to the new procedure. One of these
juridical acts revised, is Regulation (EC) 1830/2003 (B.V.9.-).
B.V.23.- Regulation Nº 1331/2008 of the European Parliament and of the Council
of 16 December, establishing a common authorisation procedure for food additives,
food enzymes and food flavourings. This Regulation lays down a common procedure
for the assessment and authorisation of food additives, food enzymes, food flavourings
and of food ingredients with flavouring properties used or intended for use in or
foodstuffs. It lays down as well, the procedural arrangements for updating the list of
substances the marketing of which is authorised in the Community pursuant to
39
Regulations (EC) 1332/2008; (EC) 1333/2008 and 1334/2008 which were approved, by
the European Parliament and the Council, the same day (see B.V.24.-, B.V.25.- and
B.V.26.-).
B.V.24.- Regulation Nº 1332/2008 of the European Parliament and of the Council
of 16 December, on food enzymes and amending Council Directive 83/417/EEC,
Council Regulation (EC) Nº 1493/1999, Directive 2000/13/EC, Council Directive
2001/112/EC and Regulation (EC) Nº 258/97. This Regulation lays down, among other
provisions, a “List of approved food enzymes”, as well as the conditions for their use
and rules for labelling. The Regulation also stated that food enzymes falling within the
scope of Regulation (EC) 1829/2003 (B.V.8.-) may be included in the above mentioned
List in accordance with now commented Regulation, only when this food enzymes is
covered by an authorisation in accordance with Regulation (EC) 1829/2003. And, as
the case may be, food enzymes remain also subject to the labelling and traceability
requirements lay down by Regulation (EC) 1830/2003 (B.V.9.-).
B.V.25.- Regulation Nº 1333/2008 of the European Parliament and of the Council
of 16 December, on food and food additives. This Regulation lays down, among other
provisions, a “List of approved food additives”, as well as the conditions for their use
and rules for labelling. The Regulation also stated that food additives falling within the
scope of Regulation (EC) 1829/2003 (B.V.8.-) may be included in the above mentioned
List in accordance with now commented Regulation, only when this food additives is
covered by an authorisation in accordance with Regulation (EC) 1829/2003. And, as
the case may be, food additives remain also subject to the labelling and traceability
requirements lay down by Regulation (EC) 1830/2003 (B.V.9.-).
B.V.26.- Regulation Nº 1334/2008 of the European Parliament and of the Council
of 16 December, on flavourings and certain food ingredients with flavouring properties
for use in and on foods and amending Council Regulation (EEC) Nº 1601/91,
Regulations (EC) Nº 2232/96 and (EC) Nº 110/2008 and Directive 2000/13/EC. This
Regulation lays down, among other provisions, a “List of approved flavourings and
source materials approved for use in and on foods”, as well as the conditions for their
use and rules for labelling. The Regulation also stated that flavourings and source
materials approved for use in and on foods falling within the scope of Regulation (EC)
40
1829/2003 (B.V.8.-) may be included in the above mentioned List in accordance with
now commented Regulation, only when this material is covered by an authorisation in
accordance with Regulation (EC) 1829/2003. And, as the case may be, flavourings and
source materials approved for use in and on foods remain also subject to the labelling
and traceability requirements lay down by Regulation (EC) 1830/2003 (B.V.9.-).
B.V.27.- Regulation (EC) Nº 596/2009 of the European Parliament and of the
Council of 18 of June, adapting a number of instruments subject to the procedure
referred in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to
the regulatory procedure with scrutiny. The Council Decision 1999/468/EC lays down
the procedures for the exercise of implementing powers conferred by the Commission.
By way of the Council Decision 2006/512/EC a new procedure was introduced
(“Regulatory procedure with scrutiny”) which allows the legislator to oppose the
adoption of draft measures where it indicates that the draft exceeds the implementing
powers provided for in the basic instrument, or that the draft is incompatible with the
aim or the content of that instrument or fails to respect the principles of subsidiarity or
proportionality.
Regulations (EC) 178/2002 and 1831/2003 are accordingly amended by the now
commented Regulation, in order to adapt it to the new implementation approach.
B.V.28.- Regulation (EC) Nº 767/2009 of the European Parliament and of the
Council of 13 July 2009 on the placing on the market and the use of feed, amending
European Parliament and the Council Regulation (EC) Nº 1831/2003 and repealing
Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives
82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC AND 96/25/EC and Commission
Decision 2004/217/EC. By way of this Regulation, the Council regulation (EC)
1831/2003 is amended.
Council Directive 82/471/EEC is also repealed and
consequently deleted from this list.
B.V.29.- Commission Regulation (EU) No 619/2011 of 24 June 2011 laying down the
methods of sampling and analysis for the official control of feed as regards presence of
genetically modified material for which an authorisation procedure is pending or the
authorisation of which has expired. Exclusively for feed and in relation to these GM
material for which an authorisation procedure is pending or the authorisation of which
41
has expired, EFSA sets, by way of this Regulation, the lowest level as the Minimum
Required Performance Limit (MRPL). “Stricto sensu” we can say that this Regulation
sets a “technical zero tolerance” of adventitious presence of these GM material in feed.
B.V.30.- Regulation (EU) No 1169/2011 of the European Parliament and of the
Council of 25 October 2011 on the provision of food information to consumers,
amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European
Parliament and of the Council, and repealing Commission Directive 87/250/EEC,
Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive
2000/13/EC of the European Parliament and of the Council, Commission Directives
2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004. In relation
to the EU provisions of food information to consumer, the 13 of December of 2014 this
Regulation will repeal Directive 2000/13/CE (B.V.5) and consequently, from this date,
the references to this Directive included in Regulation (EC) 1829/2003 (see B.V.8)has
to be considered as references to Regulation (UE) Nº 1169/2011.
B.VI.- Coexistence
B.VI.1.- Commission Decision 2005/463/EC of 21 June, establishing a network group
for the exchange and coordination of information concerning coexistence of genetically
modified, conventional and organic crops.
B.VI.2.- Commission Recommendation (2010/C 200/01) of 13 de July, on guidelines
for the development of national co-existence measures to avoid the unintended presence
of GMOs in conventional and organic crops. The aim of this Recommendation (which
delete the previous Recommendation 2003/556/EC) is to provide general principles
“...for the development of national measures to avoid the unintended presence of
GMOs in conventional and organic crops”.
On the other hand, the Recommendation left it up to Member States to develop and
implement management measures for coexistence, although it pleads for a cross-border
co-operation between neighbouring Member States “..to guarantee the effective
42
functioning of coexistence measures in border areas”, apparently ignoring the fact
that coexistence measures implemented by some neighbouring MS could be radically
different. Could de EC tell us which coexistence measures are implemented by those MS
which have forbidden the cultivation in their countries of GMOs duly approved in the
EU?.
Consequently, in my opinion it should be a priority of the EC to provide a set of
harmonised (and rational) provisions on this item.
B.VII.- GMOs in sectoral legislation
B.VIIa).- Agricultural Organic production
In the INTRODUCTION of this work I have already commented that, in my opinion, the
majority of the anti-GMO campaigns are at a certain extend, demagogical. Here we
have a clear example:
The statement that organic food “..does not consist, contain or have been produced
from GMOs…” is fairly common in both ecologists’ publications as well as in the
recurrent declarations kindly provided by relevant members of ecological organisations
(in both newspaper and other mass media).
They also consider “organically unacceptable” any food product proceeding from an
animal which for a period of time has been grown up with GM feed for a period of time
because, in their opinion, GMO food “...represent an unknown risk for the health..”.
This statement is not at all true because Regulation (EC) 834/2007 authorised in the
organic agronomical production, the use of GMO veterinary medicinal products as well
as GMO food and feed additives and “other substances”.
This means that, for instance, organic pork meat in the market could had been obtained
from animals which were injected (intra-muscular or intra-dermal) with a GMO
43
Aujeszky vaccine which contains “live (gI, tk) Pseudorabies virus genetically
modified” (this GMO vaccine was duly approved in the EU on 1992).
On the other hand, we have recently read on the newspapers that Greenpeace have
reached (free?) agreements with big distribution supermarkets by which the distribution
companies compromised to guarantee that all food product labelled with their own
trade mark “.does not consist, contain or have been produced from GMOs…”.
I dare to suggest to these big distribution companies to put visible posters in their
organic product sections informing their clients that, according to the compromise
reached with Greenpeace (to reinforce the consumer rights, that Greenpeace and I
strongly support, to know what they choose to eat) some meats and sausages
commercialised in those sections could proceed from animals that had been injected a
GMO vaccine containing live (gI, tk) Pseudorabies virus.
B.VIIa)1.- Council Regulation (EC) Nº 834/2007 of 28 June, on organic production
and labelling of organic products and repealing Regulation (EEC) 2092/91.
B.VIIb).- Medicinal products for human and veterinarian use
B.VIIb).1.- Commission Regulation (EC) Nº 540/95 of 10 March, laying down the
arrangements for reporting suspected unexpected adverse reactions which are not
serious, whether arising in the Community or in a third country, to medicinal products
for human or veterinary use authorised in accordance with the provisions of Council
Regulation (EEC) Nº 2309/93 (see B.VII.b).2.)
B.VIIb).2.- Regulation (EC) Nº 726/2004 of the European Parliament and of the
Council of 31 March, laying down Community procedures for the authorisation and
supervision of medical products for human and veterinary use and establishing an
European Medicines Agency. Similarly to Regulation (EEC) N 2309/93 which it
replaced (and repealed), it is possible to approve a GMO medical product for human or
44
veterinarian use implementing, exclusively, the provisions established by this sectorial
Regulation just because it included a procedure for environmental risk assessment
analogous to that provided by Directive 2001/18/EC (only “one key” is needed to open
“one door”). On the other hand by way of this Regulation the name of the European
Agency for the Evaluation of Medicinal Products is simplified and changed to the
European Medicines Agency.
B.VII.b).3.- Regulation (EC) Nº 219/2009 of the European Parliament and of the
Council of 11 March, adapting a number of instruments subject to the procedure
referred in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to
the regulatory procedure with scrutiny. The Council Decision 1999/468/EC lays down
the procedures for the exercise of implementing powers conferred by the Commission.
By way of the Council Decision 2006/512/EC a new procedure was introduced
(“Regulatory procedure with scrutiny”) which allows the legislator to oppose the
adoption of draft measures where it indicates that the draft exceeds the implementing
powers provided for in the basic instrument, or that the draft is incompatible with the
aim or the content of that instrument or fails to respect the principles of subsidiarity or
proportionality.
By way of the Regulation now commented, several legal acts regulating different EU
technical areas are reviewed in order to adapt them to the new procedure. One of these
juridical acts revised, is Regulation (EC) 726/2004 (B.VIIb).2.-).
B.VIIc).- Plant protection and Biocidal products
B.VII.c).1.- Council Directive 91/414/EEC of 15 July, concerning the placing of plant
protection products on the market. Plant protection products legislation was, probably,
one of the first sectoral legislation in the EU including a specific reference to the
approval procedure of GMO products under its legal framework. In accordance with
the text of its Article 1.3, the Commission had the (optimist) pretension to: “…not later
than two years after the date of this Directive..” include in the now commented
Directive, by way of the appropriate regulatory procedure, “..an specific procedure for
evaluating the risk to the environment analogous to that provided for the Directive
90/220/EEC…”. This regulatory amendment of the Directive would allow the approval
45
of a GMO plant protection product by implementing, exclusively, this Directive (the
aimed principle “one door, one key”). But, till now, the amendment above mentioned
has not been carried out. Consequently, under the current legal framework, the
approval of GMO plant protection product requires: firstly the approval of the event
implementing the provisions of the basis Directive (now Directive 2001/18/EC which
repealed Directive 90/220/EEC) and secondly the approval of the GM plant protection
product implementing the provisions of this sectoral regulation (the now commented
Directive). That is to say, we still need “two keys” to open “one door”.
B.VII.c).1.- Council Directive 98/8/EC of the European Parliament and of the
Council of 16 February, concerning the placing of biocidal products on the market. This
Directive is a “consequence” of Directive 91/414/EC on the placing of plant protection
products on the market (already repealed). In fact, biocides are known as “non
agricultural pesticides”.
B.VIIc).2.- Council Directive 2005/25/EC of 14 March, amending Annex VI to
Directive 91/414/EC as regards plant protection products containing micro-organisms.
It lays down provisions for the follow up of plant protection products containing micro
organism (including GM micro organism).
B.VIIc).2.- Commission Directive 2006/50/EC of 29 May, amending Annexes IVA
and IVB to Directive 98/8/EC of the European Parliament and of the Council
concerning the placing of biocidal products on the market. See B.VIIc).2.-
B.VII.c).3.- Directive 2008/31/EC of the European parliament and of the Council of
11 March, amending Directive 98/8/EC concerning the placing of biocidal products on
the market., as regards the implementing powers conferred to the Commission. Council
Decision 1999/468/EC (see B.I.2.) lays down the procedures for the exercise of
implementing powers conferred on the Commission (“Comitology”). A new regulatory
procedure (“Regulatory procedure with scrutiny”), and additional provisions was
included in the “Comitology” framework by way of Decision 2006/512/EC. The
Directive now commented amended Directive 98/8/EC concerning the placing of
biocidal products on the market (see B.VII.c)2.-) in order to adapt it to this new
“Comitology” framework.
46
B.VII.c).4.- Regulation (EC) Nº 1107/2009 of the European Parliament and of the
Council of 21 October, concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and 91/414/EEC. By way of its
article 48, the specific conditions for the placing on the market and use of plant
protection products containing a GMO are established. Directive 91/414/EEC will be
repealed 18 months after the entry into force of this Regulation (14 June 2011). Until
this date is reached, the reference to Directive 91/414/EEC will be maintained in this
document.
B.VII.c).5.-
Commission
Regulation
(EU)
No 544/2011
of
10 June
2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the
Council as regards the data requirements for active substances. A copy of the evaluation
of the data concerning the assessment of the risk to the environment has to be included
in the technical dossier attached to the application for the (possible) authorisation of an
“active substance” consisting in a micro-organism (including virus) genetically
modified in accordance to article 48 of Regulation (EC) 1107/2009.
B.VII.c).6.-
Commission
Regulation
(EU)
No 546/2011
of
10 June
2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the
Council as regards uniform principles for evaluation and authorisation of plant
protection products. Related to Regulation (EU) Nº 544/2011 commented in the
previous paragraph, this Regulation provided a group of uniform principles for the
evaluation and authorisation of plant protection products (chemical plan protection
products as well as plant protection products containing microorganisms)
B.VIId) Seed and Propagating material
Directive 92/33/EC on the marketing of vegetable propagating and planting material
other than seed, Directive 92/34/EC on the marketing of fruit plant propagating
material and fruit plants intended for fruit production and Directive 98/56/EC on the
marketing of propagating material of ornamental plants are globally, of course, under
47
the scope of the GMOs regulation framework. However, I have not included them in this
section because they don’t include any reference or provision in relation to this item.
B.VIId).1.- Council Directive 66/401/EEC of 14 June, on the marketing of fodder
plant seed. Genetically modified fodder plant seed placed on the market on the EU, has
to be clearly identified as GMO in the label or any other official document
accompanying the seed.
B.VIId).2.- Council Directive 66/402/EEC of 14 June, on the marketing of cereal seed.
Genetically modified cereal placed on the market on the EU, has to be clearly identified
as GMO in the label or any other official document accompanying the seed.
B.VIId).3.- Council Directive 68/193/EEC of 9 April, on the marketing of material for
vegetative propagation of the vine. See B.VIId).6.
B.VIId).4.- Council Regulation (EC) nº 2100/94 of 27 of July, on plant variety rights.
B.VIId).5.- Council Directive 1999/105/EC of 22 December, on the marketing of
forest reproductive material. Any genetically modified forest reproductive material
placed on the market on the EU, has to be clearly identified as GMO in the label or any
other official document accompanying the material.
B.VIId).6.- Council Directive
2002/11/EC of 14 February, amending Directive
68/193/EEC on the marketing of material for vegetative propagation of the vine and
repealing Directive 74/649/EEC. It deeply amended Directive 68/193/EEC including,
among others, especial requirements for placing on the market GMO vines as well as
for products derived from GMO vines falling into the scope of Regulation (EC) Nº
258/97 concerning novel foods and food ingredient.
B.VIId).7.- Council Directive 2002/53/EC of 13 June, on the common catalogue of
varieties of agricultural plant species. All genetically modified varieties of seed of any
agricultural species included in the “Common Catalogue of varieties of agricultural
species” of the EU have to be clearly identified in this Common Catalogue as GMO
varieties.
48
B.VIId).8.- Council Directive 2002/54/EC of 13 June, on the marketing of beet seed.
Genetically modified beet seed placed on the market on the EU, has to be clearly
identified as GMO in the label or any other official document accompanying the seed.
B.VIId).9.- Council Directive 2002/55/EC of 13 June, on the marketing of vegetable
seed. Genetically modified seed of vegetables plants placed on the market on the EU,
has to be clearly identified as GMO in the label or any other official document
accompanying the seed. Similarly to agricultural species, all GM varieties of seed of
vegetal species included in the “Common Catalogue of vegetable species” of the EU
have to be clearly identified in this Common Catalogue as GMO varieties.
B.VIId).10.- Council Directive 2002/56/EC of 13 June, on the marketing of seed
potatoes. Genetically modified seed potatoes placed on the market on the EU, has to be
clearly identified as GMO in the label or any other official document accompanying the
seed.
B.VIId).11.- Council Directive 2002/57/EC of 13 June, on the marketing of seed of oil
and fibre plants. Genetically modified seed of oil and fiber plants placed on the market
on the EU, has to be clearly identified as GMO in the label or any other official
document accompanying the seed.
B.VIId).12.- Council Decision 2003/17/EC of 16 December on the equivalence of field
inspections carried out in third countries on seed producing crops and on the
equivalence of seed produced in third countries. Genetically modified seed proceeding
from third countries included in the EU equivalence regime, has to be clearly identified
as GMO in the label or any other official document accompanying the seed.
Common Catalogue of varieties of agricultural plant species
13th Supplement to the 22nd complete edition of the Common Catalogue. 17 varieties
of GM maize MON 810 were included.
49
Sixth supplement to the 23rd complete edition of the Common Catalogue. 14 new
varieties of GM maize MON 810 were included.
Second supplement to the 24th complete edition of the Common Catalogue. 3 new
varieties of GM maize MON 810 were included (Germany).
Third supplement to the 24th complete edition of the Common Catalogue. 2 new
varieties of GM maize MON 810 were included (Germany).
First supplement to the 25th complete edition of the Common Catalogue. 11 new
varieties of GM maize MON 810 were included (Spain).
Fifth supplement to the 25th complete edition of the Common Catalogue. 3 new
varieties of GM maize MON 810 were included (Spain).
Sixth supplement to the 25th complete edition of the Common Catalogue. 13 new
varieties of GM maize MON 810 were included (9 Spain, 4 Czech Republic).
Seventh supplement to the 25th complete edition of the Common Catalogue. 3 new
varieties of GM maize MON 810 were included (Czech Republic).
Third supplement to the 26th complete edition to the Common Catalogue. Two new
varieties of GM maize MON 810 were included by Portugal: PR32G49 and PR32K62.
Fourth supplement to the 26th complete edition to the Common Catalogue. Two new
varieties of GM maize MON 810 were included by Germany: DKC 2950 YG and PR 39
T 47.
Sixth supplement to the 26th complete edition to the Common Catalogue. Several GM
maize varieties are included in the Common Catalogue:
=15 new varieties included by Spain: CARELLA YG; ES ARCHIPEL YG; ES
CAJOU YG; ES MAYORAL YG;n ES PAOLIS YG; ES ZODIAC YG; LG3711
YG; MAS 58 YG; MAS 71YG; PR31D21; PR31D61; PR31P43; PR32T86;
RUGBYXX YG and TABALA YG.
= 6 new varieties included by Czech Republic: DKC3350 YG; DKC3512 YG;
KARAS YG; KONTRAS YG; MAS 29YG and PR39T47.
And a GM variety included by Spain in the Common Catalogue in 2007 (THURRO YG)
is deleted from the CC..
Seventh supplement to the 26th complete edition to the Common Catalogue. Only a
single modification (in relation to mantainers) to already listed variety TABALA YG.
First supplement to the 27th complete edition to the Common Catalogue. Two varieties
were deleted (ABREGO BT and VIRIATO BT) and three new varieties were listed:
CONSUELO YG and EC6303EZA1 (listed by Spain) and ES COCARDE YG (listed by
Germany.
50
Third supplement to the 27th complete edition to the Common Catalogue. Four new
varieties were included by Portugal: LYNXX YG, MAGGI YG, MAS 52 YG and
PR34N23.
Fifth supplement to the 27th complete edition of the Common Catalogue. Four new
GM varieties were included by Germany: DKC4251YG, DKC4373YG, KVALITAS YG
and SEIDDI YG.
Sixth supplement to the 27th complete edition to the Common Catalogue. 39 new GM
varieties were included in the Common Catalogue. Spain include 22 new varieties:
ANGOON YG, AVIRRO YG, BERGXXON YG, GALEXX YG, KARTER YG,
KOTOXX, KOXXMA, LG3540 YG, PR32D80, PR32G49, PR32P27, PR33D48,
PR33T60, PR33Y72, PR34P86, PR35Y69, REMIXX, ROXXANE YG, ROXXY YG,
TIXXUS YG, TYREXX YG, VIVANI YG (BERGXXON YG was also included in the
CC by Czech Republic). 12 varieties included by Czech Republic (variety KVALITAS
YG was also included by Germany in the fifth supplement of the 27th complete
edition of the CC): ASTERI YG, BERGXXON YG, CODISCO YG, COXXIMO YG,
CRAZI YG, ESQUADRILLE YG, FRIEDRIXX YG, HEXXER YG, KVALITAS YG,
NEXXOS YG, PR38V11, TAXXOA YG. Slovak Republic include 3 new varieties:
LG3355YG, LG3475YG, PR37F81 and 3 more were: PR36B09, PR36K64, PR37D22
were included by Romania.
Seventh supplement to the 27th complete edition to the Common Catalogue (2009264A). Two new GM varieties are incorporated to the CC: DKC4627YG (included by
Slovak Republic) and PR33W86 (included by Spain).
First supplement to the 28th complete edition to the Common Catalogue. The variety
EBONY YG is included by Czech Republic
Second supplement to the 28th complete edition to the Common Catalogue. A new
reference to the variety EBONY YG in order to include its “Maduration index”. On
the other hand, varieties: ANGOON YG and PR32P76 include in the CC by Spain in,
respectively, 2009 and 2004, are now deleted.
Third supplement to the 28th complete edition to the Common Catalogue. 10 new GM
varieties are included in the CC by Portugal: DKC4491 YG; DKC4890 YG; DKC5175
YG; DKC5277 YG; DKC5590 YG; DKC6090 YG; ES BAMA YG; KARTER YG (this
variety is already in the CC included by Spain); MAS 34YG; SHOPY YG.
Fifth supplement to the 28th complete edition to the Common Catalogue. 2 new
MON810 maize varieties are included in the CC by Portugal: PR33P80 y PR35A56.
Variety PR33W86 included in the CC by Spain since 2009, is now also included by
Portugal.
Sixth supplement to the 28th complete edition to the Common Catalogue. The GM
potato AMFLORA is included in the CC by Sweden. The following MON810 maize
varieties are also included in the Common Catalogue: ANTISS YG; ATALL YG;
DKC5543YG; DKC6364YG; DKC6877YG; ES MANADE YG; LG30607YG;
NE6284KDDZ; PHILEAXX YG; PR38N91; REBOXX YG; SHEXXPIR YG y
ULYXXE YG (included by Spain); PR33P80 y PR35A56 (included by ES and PT);
51
DKC2961 YG; DKC3477 YG; ES DALIA YG; PR39D24 y YOGI BT (included by the
Czech Republic); LG3385YG; LG3410YG; PR36D81; PR37Y20 (included by
Slovakia); LG3330YG (included by Romania); PR37N02 (included by Slovakia and
Romania); LG3475YG (already in the CC included by Slovakia is now included by
Romania) and PR39T47 (already in the CC included by Czech Republic and
Germany, is now included by Slovakia). On the other hand, variety EC6003EZA1
(included in the CC by Spain in 2009) is now deleted.
Seventh supplement to the 28th complete edition to the Common Catalogue. The
following additions of GM maize MON810 varieties have been included in the
Common Catalogue: Slovakia has included ANJOU387YG; DKC4968YG; P9000Y
varieties. Spain included the variety LESAKA YG. Czech Republic has included de
variety KALFAS YG. Slovakia included also the varieties DKC3512 YG (already in
the Common Catalogue since in 2008 were included by CZ) and LG3030YG (already
in the Common Catalogue since last August when it was included by Romania).
First supplement to the 29th complete edition to the Common Catalogue. 36 MON810
varieties are included ¡¡by France!! In the CC (23 of them were new in the CC:
ANJOU 285 BT, DKC4557YG, DKC4687YG, DKC4740YG, DKC4779YG,
DKC5051YG, DKC5320, DKC5671YG, DKC5740YG, DKC6125YG, ESTRADA,
KAMEOS, LAZIXX, LG2447BT, MAS 45YG, MAS 50YG, MONUMENTAL YG,
PR35P13, PR36G13, PR38B43, RIXXER YG, TEXXAN and VAXXEN) and 13 of
them were already registered by any other Member State: BACILA, DKC5784YG, ES
PAOLIS YG, KOTOXX, KOXXMA, REMIXX, TIXXUS YG and TYREXX YG
(already included in the CC by Spain); DKC3946YG HEXXER YG qnd PR38A25
(included by Czec Republic); PR36B09 (included by Romania) and PR39V17
(already registered in the CC by Czec Republic and Germany). Surprisingly France
included also the first two varieties in the CC containing the “event” T25 (Limas 264
and Limas 415). On the other hand variety MAS 71YG (included by Spain in 2008
was deleted) and the denomination of the variety YOGI BT (included in 2010 by Czec
Republic) is changed by the denomination YOGI YG.
Third supplement to the 29th complete edition to the Common Catalogue. Eight new
MON810 GM maize varieties are included in the CC by Portugal: DKC4591 YG,
DKC5502 YG, KLIMT YG, KORREOS YG, KOXX YG, KWS KENDRAS YG, P1223Y
and TALCA YG.
Fifth supplement to the 29th complete edition to the Common Catalogue. Spain
included in the CC 4 new MON810 varieties (CARLETA YG, CORETTA YG,
PR37K93 and P8000Y). Four more MON810 varieties are included by Romania
(PRISIO YG; PR36V78; PR38A76 y TEXXEL YG). Spain registered also in the CC
the varieties: PR36K64, PR37Y20 y PR39D24 already included in the CC by,
respectively,: RO; SK and CZ. On the other hand RO registered the variety
DKC4968YG already included in the CC by SK.
Sixth supplement to the 29th complete edition to the Common Catalogue. Seven new
varieties are included in the CC (6 by CZ and 1 by SK). And France replaced CZ (?)
as registered Member State in the CC of the variety PR39V17 (this variety is also
registered in the CC by Germany.
52
Seventh supplement to the 29th complete edition to the Common Catalogue. SK
include a new MON810 variety in the CC (PR36V56) and registered also two GM
varieties already included by RO (PR37D22 y PR38A76) and one included included
in the CC by Spain (PR37K93).
List of GMO (MON810) varieties on the Common Catalogue
Aliacan BT (2004/ES)
Anjou 277 YG (2007/CZ)
Anjou 285 BT (2011/FR)
Anjou387YG (2010/SK)
Antiss YG (2010/ES)
Aristis BT (2004/ES)
Asteri YG (2009/CZ)
Asturial BT (2007/ES)
Atall YG (2010/ES)
Avirro YG (2009/ES)
Azema YG (2007/ES)
Bacila (2005/ES; 2011/FR)
Beles SUR (2007/ES)
Benji YG (2006/ES)
Bergxxon YG (2009/CZ; 2009/ES)
Bolsa (2004/FR)
Campero BT (2004/ES)
Carella YG (2008/ES)
Carleta YG (2011/ES)
Codisco YG (2009/CZ)
Consuelo YG (2009/ES)
Coretta YG (2011/ES)
Coxximo YG (2009/CZ)
Crazi YG (2009/CZ)
Cuartal BT (2004/ES)
53
DK 513 (FR/2004)
DKC2950YG (2008/DE)
DKC2961 YG (2010/CZ)
DKC3350 YG (2008/CZ)
DKC3421YG (2006/DE; 2007/CZ)
DKC3477 YG (2010/CZ)
DKC3512 YG (2008/CZ; 2010/SK)
DKC3872YG (2011/CZ)
DKC3946YG (2007/CZ; 2011/FR)
DKC4251YG (2009/DE)
DKC4373YG (2009/DE)
DKC4442YG (2005/ES)
DKC4491 YG (2010/PT)
DKC4557YG (2011/FR)
DKC4591 YG (2011/PT)
DKC4627YG (2009/SK)
DKC4687YG (2011/FR)
DKC4740YG (2011/FR)
DKC4779YG (2011/FR)
DKC4890 YG (2010/PT)
DKC4968YG (2010/SK; 2011/RO)
DKC5018YG (2007/ES)
DKC5051YG (2011/FR)
DKC5175 YG (2010/PT)
DKC5277 YG (2010/PT)
DKC5320 (2011/FR)
DKC5502 YG (2011/PT)
DKC5543YG (2010/ES)
DKC5590 YG (2010/PT)
DKC5671YG (2011/FR)
DKC5740YG (2011/FR)
DKC5784YG (2005/ES; 2011/FR)
DKC6041YG (2005/ES)
DKC6090 YG (2010/PT)
54
DKC6125YG (2011/FR)
DKC6364YG (2010/ES)
DKC6419YG (2007/ES)
DKC6451YG (2007/ES)
DKC6531YG (2007/ES)
DKC6550 (2004/ES)
DKC6575 (2004/ES)
DKC6667YG (2007/ES)
DKC6844YG (2007/ES)
DKC6877YG (2010/ES)
Ebony YG (2010/CZ)
Elgina (2004/FR; 2007/PT)
ES Archipel YG (2008/ES)
ES Bama YG (2010/PT)
ES Cajou YG (2008/ES)
ES Cocarde YG (2009/DE)
ES Dalia YG (2010/CZ)
ES Imperial (2011/CZ)
ES Limes YG (2007/CZ)
ES Manade (2010/ES)
ES Mayoral YG (2008/ES)
ES Paolis YG (2008/ES; 2011/FR)
ES Zodiac YG (2008/ES)
Esquadrille YG (2009/CZ)
Estrada (2011/FR)
Eurostar YG (2007/CZ)
Evolia YG (2007/ES)
Foggia (2005/ES)
Friedrixx YG (2009/CZ)
Galexx YG (2009/ES)
Gambier BT (2004/ES)
Helen BT (2005/ES)
Hexxer YG (2009/CZ; 2011/FR)
Jaral BT (2004/ES)
55
Kalfas YG (2010/CZ)
Kameos (2011/FR)
Kaper YG (2007/ES)
Karas YG (2008/CZ)
Karter YG (2009/ES; 2010/PT)
Klimt YG (2011/PT)
Koffi YG (2006/ES)
Kompromis YG (2011/CZ)
Kontras YG (2008/CZ)
Korreos YG (2011/PT)
Kotoxx (2009/ES; 2011/FR)
Koxxma (2009/ES; 2011/FR)
Koxx YG (2011/PT)
Krabas YG (2011/CZ)
Kuratus (2006/DE)
Kvalistas YG (2009/DE, 2009/CZ)
KXA5491 (2007/ES)
KWS 6471 YG (2011/CZ)
KWS Kendrass YG (2011/PT)
Lazixx (2011/FR)
Lesaka YG (2010/ES)
Lévina (2004/FR)
LG2447BT (2011/FR)
LG30607YG (2010/ES)
LG3233 YG (2007/CZ)
LG3330YG (2010/RO; 2010/SK)
LG3355YG (2009/SK)
LG3363YG (2011/SK)
LG3385YG (2010/SK)
LG3410YG (2010/SK)
LG3475YG (2009/SK; 2010/RO)
LG3540 YG (2009/ES)
LG3711 YG (2008/ES)
Luson BT (2007/ES)
56
Lynxx YG (2009/PT)
Maggi YG (2009/PT)
MAS 29YG (2008/CZ)
MAS 34YG (2010/PT)
MAS 45YG (2011/FR)
MAS 50YG (2011/FR)
MAS 52 YG (2009/PT)
MAS 58YG (2008/ES)
MAS 60YG (2007/ES)
MAS 71YG (2008/ES)
Monumental YG (2011/FR)
NE6284KDDZ (2010/ES)
Nexxos YG (2009/CZ)
Novelis (2004/FR)
Olimpica (2004/FR)
Oxxigen YG (2011/CZ)
P1223Y (2011/PT)
P8000Y (2011/ES)
P9000Y (2010/SK)
Phileaxx YG (2010/ES)
Placido YG (2007/ES)
Poncho YG (2007/ES)
PR31D21 (2008/ES)
PR31D61 (2008/ES)
PR31N28 (2007/ES)
PR31P43 (2008/ES)
PR32D80 (2009/ES)
PR32G49 (2008/PT ; 2009/ES)
PR32K62 (2008/PT)
PR32P27 (2009/ES)
PR32R43 (2005/ES)
PR32T86 (2008/ES)
PR32W04 (2005/ES)
PR33B51 (2007/ES)
57
PR33D48 (2009/ES)
PR33P67 (2004/ES)
PR33P80 (2010/PT; 2010/ES)
PR33T60 (2009/ES)
PR33W86 (2009/ES; 2010/PT)
PR33Y72 (2009/ES)
PR34N23 (2009/PT)
PR34N44 (2005/ES)
PR34P86 (2009/ES)
PR35A56 (2010/ES; 2010/PT)
PR35P13 (2011/FR)
PR35Y69 (2009/ES)
PR36B09 (2009/RO; 2011/FR)
PR36D81 (2010/SK)
PR36G13 (2011/FR)
PR36K64 (2009/RO; 2011/ES)
PR36R11 (2005/ES)
PR36V56 (2011/SK)
PR36V78 (2011/RO)
PR37D22 (2009/RO; 2011/SK)
PR37F81 (2009/SK)
PR37K93 (2011/ES; 2011/SK)
PR37N02 (2010/SK; 2010/RO)
PR37Y20 (2010/SK; 2011/ES)
PR38A25 (2007/CZ; 2011/FR)
PR38A76 (2011/RO; 2011/SK)
PR38B43 (2011/FR)
PR38F71 (2006/DE; 2007/CZ)
PR38N91 (2010/ES)
PR38V11 (2009/CZ)
PR39D24 (2010/CZ; 2011/ES)
PR39D82 (2007/CZ)
PR39F56 (2006/DE; 2007/CZ)
PR 39T47 (2008/DE; 2008/CZ; 2010/SK)
58
PR39V17 (2006/DE; 2007/CZ; 2011/FR)
Prisio YG (2011/RO)
Protect (2004/ES)
Reboxx YG (2010/ES)
Remixx (2009/ES; 2011/FR)
Riglos BT (2005/ES)
Rixxer YG (2011/FR)
Rocco YG (2006/ES)
Roxxane YG (2009/ES)
Roxxy YG (2009/ES)
Rugbyxx YG (2008/ES)
Seiddi YG (2009/DE)
SF1035T (2005/ES)
SF1036T (2005/ES)
SF1112T (2005/ES)
SF4701T (2007/ES)
Shexxpir YG (2010/ES)
Shopy YG (2010/PT)
Tabala YG (2008/ES)
Talca YG (2011/PT)
Taxxoa YG (2009/CZ)
Texxan (2011/FR)
Texxel YG (2011/RO)
Tixxus YG (2009/ES; 2011/FR)
Tonic YG (2007/ES)
Tyrexx YG (2009/ES; 2011/FR)
Ulyxxe YG (2010/ES)
Vaxxen (2011/FR)
Venici YG (2007/ES)
Vivani YG (2009/ES)
Yogi BT (2010/CZ)
Yogi YG (2011/CZ)
59
List of GMO (T 25) varieties on the Common Catalogue
Limas 264 (2011/FR)
Limas 415 (2011/FR)
(December 2011)
REFERENCES
-
Amat Llombart, P. 2008. Derecho de la biotecnología y los transgénicos. Ed. Tirant
lo Blanch
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Arriola Garrote, C. 2004. Etiquetado, trazabilidad y sanciones en materia de
transgénicos:
apuntes
a
una
normativa
plural.
Disponible
en:
http://www.agrodigital.com/PlArtStd.asp?CodArt=35023
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Borlaug, N.E. 2000. Ending World Hunger. The Promise of Biotechnology and the
Threat of Antiscience Zealotry. Plant Physiol 124: 487-490.
-
Brooks, G. 2002. The farm level impact of using Bt maize in Spain. Disponible en:
http://www.pgeconomics.co.uk/pdf/bt_maize_in_spain.pdf
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Cubero, J. I. 1999. Introducción a la mejora genética vegetal. Ed. Mundi Prensa,
Madrid.
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Department for Environment Food and Rural Affairs (DEFRA). 2006. Consultation
on proposals for managing the coexistence of GM, conventional and organics crops.
Ed. DEFRA, Londres.
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EFSA. 2006. Guidance Document of the Scientific Panel on Genetically Modified
Organism for the Risk Assessment of Genetically Modified Plants and Derived
Food and Feed. The EFSA Journal 99: 1-100.
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Joint Research Center. 2006. New case studies on the coexistence of GM and nonGM crops in European agriculture. Eur 22102, JRC, IPTS Technical Report Series.
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FAO. 2002. Human Development Report 2001. Making new technologies work for
human development. United Nations Development Programme. Ed. Oxford
University Press, New York.
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FAO. 2004. El Estado Mundial de la Agricultura y la Alimentación 2003-2004. La
Biotecnología Agrícola: ¿una respuesta a las necesidades de los pobres? Ed.
60
Organización de las Naciones Unidas para la Agricultura y la Alimentación.
Roma.
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García Olmedo, F. 1998. La tercera revolución verde. Plantas con luz propia. Ed.
Debate, Madrid.
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Assemblea Pagesa, Greenpeace, Plataforma transgènics fora! 2006. La imposible
coexistencia.
Disponible
en:
http://www.greenpeace.org/raw/content/espana/reports/copy-of-la-imposiblecoexisten.pdf
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Muñoz, E. (Coord..). 2006. Organismos Modificados Genéticamente. Ed. Ephemera,
Alcalá de Henares.
-
Orteu, E., Castroviejo, M. 2005. La nueva Directiva sobre responsabilidad por daños
al medio ambiente. Ambienta 42: 7-13.
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Peinado Vacas, J.J. 2004. La regulación en la UE de los Organismos Genéticamente
Modificados.
Una
aproximación
crítica.
Disponible
en:
http://www.agrodigital.com/upload/peinado.doc
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Sánchez Gil, O. 2008. La Protección de las obtenciones vegetales. El privilegio del
agricultor. MARM.
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Tomás, A. 2005. La Unión Europea y la Regulación de la Biotecnología Aplicada a
la Agricultura. Instituto de Negociaciones Agrícolas Internacionales. Disponible en:
http://www.biw.kuleuven.be/aee/clo/euwab_files/Tomas2005.pdf
Chronological List Legal Acts
International Treaties and Conventions
Convention on Biological Diversity (A.I.1.).
Rio Declaration on Environment and Development (A.I.2.).
Cartagena Protocol on Biosafety to the Convention on Biological Biodiversity
(A.I.3.)
International Treaty on Plant Genetic Resources for Food and Agriculture (A.I.4.)
International Plant Protection Convention (A.I.5.)
61
European Union Legislation
Regulations:
Council Regulation (EC) nº 2100/94 of 27 of July, on plant variety rights. (B.VIId).4.Commission Regulation (EC) Nº 540/95 of 10 March, laying down the arrangements
for reporting suspected unexpected adverse reactions which are not serious, whether
arising in the Community or in a third country, to medicinal products for human or
veterinary use authorised in accordance with the provisions of Council Regulation
(EEC) Nº 2309/93. (B.VIIb).1.)
Regulation (EC) Nº 258/97 of the European Parliament and of the Council of 27
January, concerning novel food and novel food ingredients. (B.V.4.)
Regulation (EC) Nº 178/2002 of the European Parliament and of the Council of 28
January, laying down the general principles and requirements of food law, establishing
the European Food Safety Authority and laying down procedures in matters of food
safety. (B.V.5.)
Regulation (EC) Nº 1946/2003 of the European Parliament and the Council of 15
July, on transboundary movements of genetically modified organisms. (A.II.2.)
Regulation (EC) Nº 1829/2003 of the European Parliament and of the Council of 22
September, on genetically modified food and feed. (B.V.8.)
Regulation (EC) Nº 1830/2003 of the European Parliament and of the Council of 22
September concerning the traceability and labelling of genetically modified organisms
and the traceability of food and feed products produced from genetically modified
organisms and amending Directive 2001/18/EC. (B.V.9.)
Regulation (EC) Nº 1831/2003 of the European Parliament and of the Council of 22
September on additives for use in animal nutrition. (B.V.10.)
Commission Regulation (EC) Nº 65/2004 of 14 January, establishing a system for the
development and assignment of unique identifiers for genetically modified organisms.
(B.I.4.)
Commission Regulation (EC) Nº 641/2004 of 6 April, on detailed rules for the
implementation of Regulation (EC) Nº 1829/2003 of the European Parliament and of
the Council as regards the application for the authorisation of new genetically modified
food and feed, the notification of existing products and adventitious or technically
unavoidable presence of genetically modified material which has benefited from a
favourable risk evaluation. (B.V.11.)
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Regulation (EC) Nº 726/2004 of the European Parliament and of the Council of 31
March, laying down Community procedures for the authorisation and supervision of
medical products for human and veterinary use and establishing an European Medicines
Agency. (B.VIIb).2.)
Regulation (EC) Nº 882/2004 of the European Parliament and of the Council of 29
April, on official controls performed to ensure the verification of compliance with feed
and food law, animal health and animal welfare rules. (B.V.14.)
Commission Regulation (EC) Nº 2230/2004 of 23 December, laying down detailed
rules for the implementation European Parliament and Council Regulation (EC) Nº
178/2002 with regard to the network of organisation operating in the fields within the
European Food Safety Authority’s mission. (B.V.16.)
Commission Regulation (EC) Nº 575/2006 of 7 April, amending Regulation (EC) Nº
178/2002 of the European Parliament and of the Council as regards the number and
names of the permanent Scientific Panels of the European Food Safety Authority.
(B.V.17.)
Regulation (EC) Nº 1924/2006 of the European Parliament and of the Council of 20
December, on nutrition and health claims made on foods. (B.V.18.)
Commission Regulation (EC) Nº 1981/2006 of 22 December, on detailed rules for the
implementation of Article 32 of Regulation (EC) Nº 1829/2003 of the European
Parliament and of the Council as regards the Community reference laboratory for
genetically modified organisms. (B.V.19.)
Council Regulation (EC) Nº 834/2007 of 28 June, on organic production and labelling
of organic products and repealing Regulation (EEC) 2092/91. (B.VIIA)1.)
Regulation (EC) Nº 298/2008 of the European Parliament and of the Council of 11
March, amending Regulation (EC) Nº 1829/2003 on genetically modified food and
feed, as regards the implementing powers conferred on the Commission. (B.V.20.)
Regulation (EC) Nº 1137/2008 of the European Parliament and of the Council of 22
October adapting a number of instruments subject to the procedure laid down in Article
251 of the Treaty to the Council Decision 1999/468/EC, with regard to the regulatory
procedure with scrutiny (B.V.22.-).
Regulation Nº 1331/2008 of the European Parliament and of the Council of 16
December, establishing a common authorisation procedure for food additives, food
enzymes and food flavourings (B.V.23.-).
Regulation Nº 1332/2008 of the European Parliament and of the Council of 16
December, on food enzymes and amending Council Directive 83/417/EEC, Council
Regulation (EC) Nº 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC
and Regulation (EC) Nº 258/97 (B.V.24.-).
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Regulation Nº 1333/2008 of the European Parliament and of the Council of 16
December, on food and food additives (B.V.25.-).
Regulation Nº 1334/2008 of the European Parliament and of the Council of 16
December, on flavourings and certain food ingredients with flavouring properties for
use in and on foods and amending Council Regulation (EEC) Nº 1601/91, Regulations
(EC) Nº 2232/96 and (EC) Nº 110/2008 and Directive 200013/EC (B.V.26.-).
Regulation (EC) Nº 219/2009 of the European Parliament and of the Council of 11
March, adapting a number of instruments subject to the procedure referred in Article
251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory
procedure with scrutiny (B.VIIb).3.-).
Regulation (EC) Nº 596/2009 of the European Parliament and of the Council of 18
of June, adapting a number of indtruments subject to the procedure referred in Article
251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory
procedure with scrutiny (B.V.27.-).
Regulation (EC) Nº 767/2009 of the European Parliament and of the Council of 13
July 2009 on the placing on the market and the use of feed, amending European
Parliament and the Council Regulation (EC) Nº 1831/2003 and repealing Council
Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives
82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC AND 96/25/EC and Commission
Decision 2004/217/EC (B.V.28.-).
Regulation (EC) Nº 1107/2009 of the European Parliament and of the Council of 21
October, concerning the placing of plant protection products on the market and
repealing Council Directives 79/117/EEC and 91/414/EEC. (B.VII.c).4.-).
Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation
(EC) No 1107/2009 of the European Parliament and of the Council as regards the data
requirements for active substances (B.VII.c).5.-)
Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation
(EC) No 1107/2009 of the European Parliament and of the Council as regards uniform
principles for evaluation and authorisation of plant protection products (B.VII.c).6.-).
Commission Regulation (EU) No 619/2011 of 24 June 2011 laying down the methods
of sampling and analysis for the official control of feed as regards presence of
genetically modified material for which an authorisation procedure is pending or the
authorisation of which has expired (B.V.29.-).
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of
25 October 2011 on the provision of food information to consumers, amending
Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament
and of the Council, and repealing Commission Directive 87/250/EEC, Council
Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the
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European Parliament and of the Council, Commission Directives 2002/67/EC and
2008/5/EC and Commission Regulation (EC) No 608/2004 (B.V.30.-).
Directives
Council Directive 66/401/EEC of 14 June, on the marketing of fodder plant seed.
(B.VIId).1.)
Council Directive 66/402/EEC of 14 June, on the marketing of cereal seed.
(B.VIId).2.)
Council Directive 68/193/EEC of 9 April, on the marketing of material for vegetative
propagation of the vine. (B.VIId).3.)
Council Directive 82/471/EEC of 30 June, concerning certain products used in animal
nutrition. (B.V.1.)
Council Directive 88/388/EEC of 22 June, on approximation of the laws of the
Member States relating to flavourings for use in foodstuffs and to source materials for
their production. (B.V.1.)
Council Directive 89/107/EC of 21 December, on the approximation of the laws of the
Member States concerning food additives authorised for use in foodstuffs used intended
for human consumption. (B.V.2.)
Directive 95/2/EC of the European Parliament and of the Council of 20 February,
on food additives other than colours and sweeteners. (B.V.3.)
Council Directive 98/8/EC of the European Parliament and of the Council of 16
February, concerning the placing of biocidal products on the market. (B.VII.c).1.)
Directive 98/44/EC of the European Parliament and the Council of 6 June, on the
legal protection of biotechnological inventions. (B.I.1.)
Council Directive 1999/105/EC of 22 December, on the marketing of forest
reproductive material. (B.VIId).4.)
Directive 2000/13/EC of the European Parliament and of the Council of 20 March,
on the approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs. (B.V.5.)
Directive 2001/18/EC of the European Parliament and the Council of 12 May, on
the deliberate release into the environment of genetically modified organisms and
repealing Council Directive 90/220/EEC. (B.III.1.)
65
Commission Directive 2001/101/EC of 26 November, amending Directive 2000/13/EC
of the European Parliament and the Council on the approximation of the laws of the
Member States relating to the labelling, presentation and advertising of foodstuffs.
(B.V.6.)
Council Directive 2002/11/EC of 14 February, amending Directive 68/193/EEC on the
marketing of material for vegetative propagation of the vine and repealing Directive
74/649/EEC. (B.VIId).5.)
Council Directive 2002/53/EC of 13 June, on the common catalogue of varieties of
agricultural plant species. (B.VIId).6.)
Council Directive 2002/54/EC of 13 June, on the marketing of beet seed. (B.VIId).7.)
Council Directive 2002/55/EC of 13 June, on the marketing of vegetable seed.
(B.VIId).8.)
Council Directive 2002/56/EC of 13 June, on the marketing of seed potatoes.
(B.VIId).9.)
Council Directive 2002/57/EC of 13 June, on the marketing of seed of oil and fibre
plants. (B.VIId).10.)
Directive 2003/89/EC of the European Parliament and of the Council of 10
November, amending Directive 2000/13/EC as regards indication of the ingredients
present in foodstuffs. (B.V.11.)
Directive 2004/35/EC of the European Parliament and the Council of 21 April, on
environmental liability with regard to the prevention and remedying of environmental
damage. (B.I.5.)
Commission Directive 2006/50/EC of 29 May, amending Annexes IVA and IVB to
Directive 98/8/EC of the European Parliament and of the Council concerning the
placing of biocidal products on the market. (B.VIIc).2.)
Directive 2008/27/EC of the European Parliament and of the Council of 11 March,
amending Directive 201/18/EC of the European Parliament and of the Council on the
deliberate release into the environment of genetically modified organisms as regards the
implementing powers conferred on the Commission. (B.III.17.)
Directive 2008/31/EC of the European Parliament and of the Council of 11 March,
amending Directive 98/8/EC concerning the placing of biocidal products on the market.,
as regards the implementing powers conferred to the Commission. (B.VII.c).3.)
Directive 2009/41/EC of the European Parliament and of the Council of 6 May
2009 on the contained use of genetically modified micro-organisms (B.II.1.-).
Decisions
66
Commission Decision 93/572/EEC of 19 October, concerning the placing on the
market of a product containing genetically modified organisms pursuant to Article 13 of
Council Directive 90/220/EEC. (B.IV.1.)
Commission Decision 94/385/EC of 8 June, concerning the placing on the market of a
product consisting of a genetically modified organism, seed oh herbicide resistant
tobacco variety ITB 1000 OX, pursuant to Article 13 of Council Directive 90/220/EEC.
(B.IV.2.)
Commission Decision 94/505/EC of 18 July, amending the Decision of 18 December
1992 concerning the placing on the market of a GMO product, the vaccine Nobi.Porvac
Aujeszjy live (gl, tk) pursuant Article 13 of Council Directive 90/220/EEC. (B.IV.3.)
Commission Decision 96/158/EC of 6 February, concerning the placing on the market
of a product consisting of a genetically modified organism, hybrid herbicide-tolerant
swede-rape seeds (Brassica napus L. oleífera Metzq. MS1Bn x RF1Bn) pursuant to
Article 13 of Council Directive 90/220/EEC. (B.IV.4.)
Commission Decision 96/281/EC of 3 April, concerning the placing on the market a
genetically modified soya beans (Glycine max L.) with increased tolerance to the
herbicide glyphosate, pursuant to Council Directive 90/220/EEC. (B.IV.5.)
Commission Decision 96/424/EC of 20 May, concerning the placing on the market of
genetically modified male sterile chicory (Cichorium intybus L.) with partial tolerance
to the herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC.
Commission Decision 97/98/EC of 23 January, concerning the placing on the market
of genetically modified maize (Zea mays L.) with the combine modification for
insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the
herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC. (B.IV.7.)
Commission Decision 97/392/EC of 6 June, concerning the placing on the market of
genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1xRF1),
pursuant to Council Directive 90/220/EEC. (B.IV.8.)
Commission Decision 97/393/EC of 6 June, concerning the placing on the market of
genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1xRF2),
pursuant to Council Directive 90/220/EEC. (B.IV.9.)
Commission Decision 97/549/EC of 14 July, concerning the placing on the market of
T102-test (Streptococcus thermophilus T102) pursuant to Council Directive
90/220/EEC. (B.IV.10.)
Commission Decision 98/291/EC of 22 April, concerning the placing on the market of
genetically modified spring swede-rape (Brassica napus L. ssp. oleifera) pursuant to
Council Directive 90/220/EEC. (B.IV.11.)
67
Commission Decision 98/292/EC of 22 April, concerning the placing on the market of
genetically modified maize (Zea mays L. Line Bt-11) pursuant to Council Directive
90/220/EEC. (B.IV.12.)
Commission Decision 98/293/EC of 22 April, concerning the placing on the market of
genetically modified maize (Zea mays T25) pursuant to Council Directive 90/220/EEC.
(B.IV.13.)
Commission Decision 98/294/EC of 22 April, concerning the placing on the market of
a genetically modified maize (Zea mays L. line MON 80) pursuant to Council Directive
90/220/EEC. (B.IV.14.)
Council Decision 1999/468/EC of 28 June, laying down the procedures for the exercise
of implementing powers conferred on the Commission. (B.I.2.)
Commission Decision 2000/443/EC of 18 May, amending Decision 97/404/EC setting
up a Scientific Steering Committee and Decision 97/579/EC setting up committees in
the area of the consumer health and food safety. (B.I.3.)
Commission Decision 2002/623/EC of 24 July, establishing guidance notes
supplementing Annex II to Directive 2001/18/EC of the European Parliament and the
Council on the deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC. (B.III.2.)
Council Decision 2002/628/EC of 25 June, concerning the conclusion, on behalf of the
European Community, of the Cartagena Protocol on Biosafety. (A.II.1.)
Council Decision 2002/811/EC of 3 October, establishing guidance notes
supplementing Annex VII of the Directive 2001/18/EC of the European Parliament and
the Council on the deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC. (B.III.3.)
Council Decision 2002/812/EC of 3 October, establishing pursuant to Directive
2001/18/EC of the European Parliament and the Council the summary information
format relating to the placing on the market of genetically modified organism as or in
products. (B.III.4.)
Council Decision 2002/813/EC of 3 October, establishing pursuant Directive
2001/18/EC of the European Parliament and the Council the summary notification
information format for notifications concerning the deliberate release into the
environment of genetically modified organisms for purposes other than placing in the
market. (B.III.5.)
Council Decision 2003/17/EC of 16 December on the equivalence of field inspections
carried out in third countries on seed producing crops and on the equivalence of seed
produced in third countries. (B.VIId).11.)
Commission Decision 2003/653/EC of 2 September, relating to national provisions on
banning the use of genetically modified organisms in the region of Upper Austria
pursuant to Article 95(5) of the EC Treaty. (B.III.6.)
68
Commission Decision 2003/701/EC of 29 September, establishing pursuant to
Directive 2001/18/EC of the European Parliament and the Council, a format for
presenting the result of the deliberate release into the environment of genetically
modified higher plant other than placing on the market. (B.III.7.)
Commission Decision 2004/204/EC of 23 February, laying down detailed
arrangements for the operation of the registers for recording information on genetic
modifications of GMOs, provided for in Directive 2001/18/EC of the European
Parliament and of the Council. (B.III.8.)
Commission Decision 2004/613/EC of 6 August, concerning the creation of an
advisory group on the food chain and animal and plant health. (B.V.13.)
Commission Decision 2004/643/EC of 19 July, concerning the placing on the market,
in accordance with Directive 2001/18/EC of the European Parliament and the Council,
of a maize product (Zea mays L. line NK603) genetically modify for glyphosate
tolerance. (B.IV.15.)
Council Decision 2004/869/EC of 24 February, concerning the conclusion, on behalf of
the European Community, of the International Treaty of the Plant Genetic Resources for
Food and Agriculture. (A.II.3.)
Commission Decision 2005/448/EC of 3 March, authorising the placing on the market
of food and food ingredients derived from genetically modified maize line NK 603 as
novel food or food ingredients under Regulation (EC) Nº 258/97 of the European
Parliament and the Council. (B.IV.16.)
Commission Decision 2005/463/EC of 21 June, establishing a network group for the
exchange and coordination of information concerning coexistence of genetically
modified, conventional and organic crops. (B.VI.2.)
Council Decision 2005/523/EC of 30 May, approving the accession of the European
Community for the Protection of New Varieties of Plants, as revised at Geneva on 19
March 1991. (A.II.4.)
Commission Decision 2005/608/EC of 8 August, concerning the placing on the market,
in accordance with Directive 2001/18/Ec of the European Parliament and of the
Council, of a maize product (Zea mays L. line MON 863) genetically modify for
resistance to corn rootworm. (B.IV.17.)
Commission Decision 2005/635/EC of 31 August, concerning the placing on the
market, in accordance with Directive 2001/18/EC of the European Parliament and the
Council, of an oilseed rape product (Brassica napus line GT 73) genetically modified
for tolerance to the herbicide glyphosate. (B.IV.18.)
Commission Decision 2005/772/EC of 3 November, concerning the placing on the
market, in accordance with Directive 2001/18/EC of the European Parliament and the
Council, of a maize product (Zea mays L. line 1507) genetically modify for resistance to
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certain lepidopteran pests and for tolerance to the herbicide glufosinate- ammonium.
(B.IV.20.)
Commission Decision 2006/10 EC of 10 January, concerning the provisional
prohibition in Greece of the marketing of seeds of maize hybrids with the genetic
modification MON 810 inscribed in the common catalogue of varieties of agricultural
plant species, pursuant to Directive 2002/53/EC. (B.III.9.)
Commission Decision 2006/47/EC of 16 January, concerning the placing on the
market, in accordance with Directive 2001/18/EC of the European Parliament and the
Council, of a maize product (Zea mays L. hybrid MON 863 x MON 810) genetically
modified to resistance to corn rootworm and certain lepidopteran pests of maize.
(B.IV.21.)
Commission Decision 2006/68/EC of 13 January, authorising the placing on the
market of food and food ingredients derived from genetically modified maize line MON
863 as a novel food or novel food ingredients under Regulation (EC) Nº 258/97 of the
European Parliament and of the Council. (B.IV.22.)
Commission Decision 2006/197/EC of 3 March, authorising the placing on the market
of food containing, consisting of or produced from genetically modified maize line 1507
(DAS-01507-1) pursuant to Regulation Nº 1829/2003 of the European Parliament and
of the Council. (B.IV.23.)
Commission Decision 2006/255/EC of 14 March, concerning national provisions
imposing on supermarkets an obligation to place genetically modified food on separate
shelves from non-genetically modified food, notified by Cyprus pursuant to Article
95(5) of the EC Treaty. (B.III.10.)
Commission Decision 2006/335/EC of 8 may, authorising the Republic of Poland to
prohibit on its territory the use of 16 genetically modified varieties of maize with the
genetic modification MON 810 listed in the Common catalogue of varieties of
agricultural plant species, pursuant to Council Directive 2002/53/EC. (B.III.11.)
Council Decision 2006/512/EC of 17 July 2006 amending Decision 1999/468/EC
laying down the procedures for the exercise of implementing powers conferred on the
Commission (B.I.6.-).
Commission Decision 2006/578/EC of 23 August, on emergency measures regarding
the non-authorised genetically modified organism LL RICE 601 in rice products.
(B.III.12.)
Commission Decision 2006/601/EC of 5 September, on emergency measures regarding
the non-authorised genetically modified organism LL RICE 601 in rice products.
(B.III.13.)
Commission Decision 2006/754/EC of 6 November, amending Decision 2006/601/EC
on emergency measures regarding the non-authorised genetically modified organism LL
RICE 601 in rice products. (B.III.14.)
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Commission Decision 2007/232/EC of 26 March, concerning the placing on the
market, in accordance with Directive 2001/18/EC of the European Parliament and of the
Council, of oilseed rape products (Brassica napus L. lines Ms8, Rf3 and Ms8xRf3)
genetically modify for tolerance to the herbicide glufosinate-ammonium. (B.IV.24.)
Commission Decision 2007/304/EC of 25 April, on the withdrawal from the market of
Bt176 (SYN-EV176-9) maize and its derived products. (B.IV.25.)
Commission Decision 2007/305/EC of 25 April, on the withdrawal from the market of
Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived
products. (B.IV.26.)
Commission Decision 2007/306/EC of 25 April, on the withdrawal from the market of
Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived
product. (B.IV.27.)
Commission Decision 2007/307/EC of 25 April, on the withdrawal from the market of
Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products. (B.IV.28.)
Commission Decision 2007/308/EC of 25 April, on the withdrawal from the market of
products derived from GA21x MON810 (MON-ØØØ21-9xMONØØ81Ø-6) maize.
(B.IV.29.)
Commission Decision 2007/364/EC of 23 May, concerning the placing on the market,
in accordance with Directive 2001/18/EC of the European Parliament and the Council,
of a carnation (Dianthus caryophylus L. line 123.2.38) genetically modified for flower
colour. (B.IV.30.)
Commission Decision 2007/692/EC of 24 October, authorising the placing on the
market of food and feed produced from genetically modified sugarbeet H7-1 (KMØØØH71-4) pursuant to Regulation (EC) Nº 1829/2003 of the European Parliament and
of the Council. (B.IV.31.)
Commission Decision 2007/701/EC of 24 October, authorising the placing on the
market of products containing, consisting of and produced from genetically modified
maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to Regulation
1829/2003 of the European Parliament and of the Council. (B.IV.32.)
Commission Decision 2007/702/EC of 24 October, authorising the placing on the
market of products containing, consisting of and produced from genetically modified
maize 59122 (DAS-59122-7) pursuant to Regulation 1829/2003 of the European
Parliament and of the Council. (B.IV.33.)
Commission Decision 2007/703/EC of 24 October, authorising the placing on the
market of products containing, consisting of and produced from genetically modified
maize 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) pursuant to Regulation
1829/2003 of the European Parliament and of the Council. (B.IV.34.)
Commission Decision 2008/62/EC of 12 October 2007, relating to Articles 111 and
172 of the Polish Draft Act on Genetically Modified Organisms, notified by the
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Republic of Poland pursuant to Article 95(5) of the EC Treaty as derogations from
provisions of Directive 201/18/EC of the European Parliament and of the Council on the
deliberate release into the environment of genetically modified organisms. (B.III.15.)
Commission Decision 2008/162/EC of 26 February, amending Decision 2006/601/EC
on emergency measures regarding the non-authorised genetically modified organism LL
RICE 601 in rice products. (B.III.16.)
Commission Decision 2008/279/EC of 28 March, repealing Decision 2006/69/EC
authorising the placing on the market of foods and food ingredients produced from
genetically modified Roundup Ready maize line GA21 as novel food and novel food
ingredients under Regulation (EC) nº 258/97 of the European Parliament and of the
Council. (B.IV.35.)
Commission Decision 2008/280/EC of 28 March, authorising the placing on the
market of products containing, consisting of and produced from genetically modified
maize GA21 (MON-ØØØ21-9) pursuant to Regulation 1829/2003 of the European
Parliament and of the Council. (B.IV.36.)
Commission Decision 2008/289/EC of 3 April, on emergency measures regarding the
unauthorised modified organism Bt 63 in rice products. (B.III.18.)
Commission Decision 2008/470/EC of 7 May, concerning the provisional prohibition
of the use and sale in Austria of genetically modified maize (Zea mays L. line T25)
pursuant to Directive 2001/18/EC of the European Parliament and of the Council.
(B.III.19.)
Commission Decision 2008/721/EC of 5 August, setting up an advisory structure of
Scientific Committees and experts in the field of consumer safety, public heath and the
environment and repealing Decision 2004/210/EC. (B.V.21.)
Commission Decision 2008/730/EC of 8 September, authorising the placing on the
market of products containing, consisting of and produced from genetically modified
soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation 1829/2003 of the
European Parliament and of the Council. (B.IV.37.).
Commission Decision 2008/837/EC of 29 October, Authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) Nº 1829/2003 of the
European Parliament and of the Council. (B.IV.38.)
Commission Decision 2008/933/EC of 4 December, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) Nº 1829/2003 of the
European Parliament and of the Council (B.IV.39.-).
Commission Decision 2009/184/EC of 10 March, authorising the placing on the
market of products containing or produced from genetically modified oilseed rape T45
(ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third
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countries until 2005 pursuant to Regulation (EC) nº 1829/2003 of the European
Parliament and of the Council (B.IV.40.-).
Commission Decision 2009/244/EC concerning the placing on the market, in
accordance with Directive 2001/18/Ec of the European Parliament and of the Council,
of a carnation (Dianthus caryophylus L., line 123.8.12) genetically modified for flower
colour (B.IV.41.-).
Commission Decision 2009/770/EC of 13 October, establishing standard reporting
formats for presenting the monitoring results of the deliberate release into the
environment of genetically modified organisms, as or in products, for the purpose of
placing on the market, pursuant to Directive 2001/18/EC of the European Parliament
and of the Council. (B.III.20.- )
Commission Decision 2009/813/EC of 30 October, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON 89034 (MON-89Ø34-3) pursuant to Regulation (EC) Nº 1829/2003 of the
European Parliament and of the Council. (B.IV.42.-).
Commission Decision 2009/814/EC of 30 October, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON 88017 (MON-88Ø17-3) pursuant to Regulation (EC) Nº 1829/2003 of the
European Parliament and of the Council. (B.IV.43.-).
Commission Decision 2009/815/EC of 30 October, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize 59122xNK603 (DAS-59122-7xMON-ØØ6Ø3-6) pursuant to Regulation (EC) Nº
1829/2003 of the European Parliament and of the Council. (B.IV.44.- )
Commission Decision 2009/828/EC of 3 November, relating to the draft Regional
Legislative Decree declaring the Autonomous Region of Madeira to be an Area Free of
Genetically Modified Organisms, notified by the Republic of Portugal pursuant to
Article 95(5) of the EC Treaty. (B.III.21.-).
Commission Decision 2009/866/EC of 30 November, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) Nº 1829/2003 of the
European Parliament and of the Council. (B.IV.45.-).
Commission Decision 2010/135/EU of 2 March 2010 concerning the placing on the
market, in accordance with Directive 2001/18/EC of the European Parliament and of the
Council, of a potato product (Solanum tuberosum L. lines EH92-527-1) genetically
modified for enhanced content of the amylopectin component of starch (B.IV.46.-).
Commission Decision 2010/136/EU of 2 March 2010, authorising the placing on the
market of feed produced from genetically modified potato EH92-527-1 (BPS-25271-9)
and the adventitious or technically unavoidable presence of the potato in food and other
feed products under Regulation (EC) Nº 1829/2003 of the European Parliament and of
the Council (B.IV.47.-).
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Commission Decision 2010/139/EU of 2 March 2010 authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON863xMON810xNK603 (MON-ØØ863-5xMON-ØØ81Ø-6xMON-ØØ6Ø36) pursuant to Regulation (EC) Nº 1829/2003 of the European Parliament and of the
Council (B.IV.48.-).
Commission Decision 2010/140/EU of 2 March 2010 authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON863xMON810 (MON-ØØ863-5xMON-ØØ81Ø-6) pursuant to Regulation
(EC) Nº 1829/2003 of the European Parliament and of the Council (B.IV.49.-).
Commission Decision 2010/141/EU of 2 March 2010 authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON863xNK603 (MON-ØØ863-5xMON-ØØ6Ø3-6) pursuant to Regulation
(EC) Nº 1829/2003 of the European Parliament and of the Council (B.IV.50.-).
Commission Decision 2010/419/EU of 28 of July, renewing the authorisation for
continued marketing of products containing, consisting of, or produced from genetically
modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients
containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to Regulation
(EC) Nº 1829/2003 of the European Parliament and of the Council and repealing
Decision 2004/657/EC (B.IV.51.-).
Commission Decision 2010/420/EU of 28 of July, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON89034xNK603 (MON-89Ø34-3xMON-ØØ6Ø3-6) pursuant to regulation
(EC) Nº 1829/2003 of the European Parliament and of the Council (B.IV.52.-).
Commission Decision 2010/426/EU of 28 of July, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9) pursuant to regulation (EC) Nº
1829/2003 of the European Parliament and of the Council (B.IV.53.-).
Commission Decision 2010/428/EU of 28 of July, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize 59122x1507xNK603 (DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6) pursuant to
regulation (EC) Nº 1829/2003 of the European Parliament and of the Council
(B.IV.54.).
Commission Decision 2010/429/EU of 28 of July, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON 88017xMON810 (MON-88Ø17-3xMON-ØØ81Ø-6) pursuant to regulation
(EC) Nº 1829/2003 of the European Parliament and of the Council (B.IV.55.-).
Commission Decision 2010/432/EU of 28 of July, authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize 1507x59122 (DAS-Ø15Ø7-1xDAS-59122-7) pursuant to regulation (EC) Nº
1829/2003 of the European Parliament and of the Council (B.IV.56.-).
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Commission Decision 2011/354/EU of 17 June 2011 authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No 1829/2003 of the
European Parliament and of the Council (B.IV.57.-).
Commission Decision 2011/365/EU of 17 June 2011 amending Decision 2006/197/EC
as regards the renewal of the authorisation to place on the market existing feed produced
from genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to Regulation
(EC) No 1829/2003 of the European Parliament and of the Council (B.IV.58.-).
Commission Decision 2011/366/EU of 17 June 2011 authorising the placing on the
market of products containing, consisting of, or produced from genetically modified
maize MON 89034 × MON 88017 (MON-89Ø34-3xMON-88Ø17-3) pursuant to
Regulation (EC) No 1829/2003 of the European Parliament and of the Council
(B.IV.59.-)
Recommendations
Commission Recommendation 2004/787//EC of 4 October, on technical guidance for
sampling and detection of genetically modified organisms as or in products in the
context of Regulation (EC) Nº 1830/2003. (B.V.15.)
Commission Recommendation 2005/637/EC of 16 August, concerning the measures
to be taken by the consent holder to prevent any damage to health and environment in
the event of an accident spillage of an oilseed rape (Brassica napus line GT 73)
genetically modified for tolerance to the herbicide glyphosate. (B.IV.19.)
Commission Recommendation (2010/C 200/01) of 13 de July, on guidelines for the
development of national co-existence measures to avoid the unintended presence of
GMOs in conventional and organic crops (B.VI.2.-).
December 2011
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