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Brussels, Belgium
1 July 2002
This questions and answers fact sheet is divided into two
sections; Part A covers legislation in force; Part B covers the
legislative proposals on tracability and labelling put forward
in July 2001
Part 1 -
Legislation in force
Part 2 -
New legislative proposals
Annex 1
Annex 2
Annex 3
Annex 4
Annex 5
Footnotes
French and German versions
of this document are available through
http://europa.eu.int/comm/press_room/index.htm
What are GMOs and GMMs?
Genetically modified organisms (GMOs) and genetically modified
micro-organisms (GMMs) can be defined as organisms (and
micro-organisms) in which the genetic material (DNA) has been
altered in a way that does not occur naturally by mating or
natural recombination. The technology is often called "modern
biotechnology" or "gene technology", sometimes also "recombinant
DNA technology" or "genetic engineering". It allows selected
individual genes to be transferred from one organism into
another, also between non-related species.
PART A : LEGISLATION IN FORCE
What is the current legislation in the EU on GMOs?
Community legislation on GMOs has been in place since the early
1990s and throughout the decade, this regulatory framework has
been further extended and refined. The EU introduced specific
legislation designed to protect its citizens' health and the
environment while simultaneously creating a unified market for
biotechnology.
The main legislation which authorises experimental releases and
placing on the market of genetically modified organisms (GMOs)
in the Community is currently Directive 90/220/EEC. A new,
updated Directive 2001/18/EC on the deliberate release of
genetically modified organisms was adopted by the European
Parliament and the Council of Ministers in March 2001 and will
enter into force on 17 October 2002.
Directive 90/220/EEC put in place a step-by-step approval
process on a case by case assessment of the risks to human
health and the environment before any GMO or product consisting
of or containing GMOs can be released into the environment or
placed on the market.
Products derived from GMOs, such as paste or ketchup from a GMO
tomato are not covered by this horizontal Directive but by
vertical, sectoral legislation, for example the Regulation on
Novel Foods and Novel Food Ingredients of 27 January
1997(Regulation (EC) 258/97). Directive 90/219/EEC as amended by
Council Directive 98/81/EC on the contained use of GMMs which
regulates the contained use of GMMs for research and industrial
purposes.
How does the current risk assessment procedure work?
The safety of GMOs depends on the characteristics of the
inserted gene(s), the final organism that is produced and its
application The objective of the risk assessment is to identify
and evaluate potential adverse effects of the GMO(s), either
direct or indirect, immediate or delayed, taking also into
account the cumulative and long term effects on human health and
the environment which the deliberate release or the placing on
the market of GMOs may have. The risk assessment also looks
specifically how the GM product was developed and examines the
risks associated with the gene products in the product (for
example toxic or allergenic proteins), and the possibility of a
gene-transfer (for example of antibiotic resistance genes).
The methodology of the risk assessment is as follows:
- Identification of any
characteristics of the GMO(s) which may cause adverse effects;
- Evaluation of the potential
consequences of each adverse effect;
- Evaluation of the likelihood
of the occurrence of each identified potential adverse effect;
- Estimation of the risk posed
by each identified characteristic of the GMO(s);
- Application of management
strategies for risks from the deliberate release or placing on
the market of GMO(s);
- Determination of the overall
risk of the GMO(s).
The Scientific Committee on
Plants (SCP) has issued opinions on 17 GM plants under Directive
90/220/EEC. In one case an unfavourable opinion was given due to
an insufficient risk assessment of the presence of a number of
uncharacterised genes and particularly the gene which confers
resistance to amikacin, a clinically important antibiotic. This
application was withdrawn.
The Scientific Committee on Food is responsible for opinions
relating to Novel Foods. This Committee has issued 3 favourable
opinion on food of plant origin (tomato and maize) and 4 on
products of microbial origin.
What is the current procedure for approval of the release of
GMOs into the environment?
Under Directive 90/220/EEC (Directive 2001/18/EC from October
2002 ), a company intending to market a GMO must first submit an
application to the competent national authority of the Member
State where the product is to be first placed on the market. For
experimental releases, notifications are examined and consent
granted as appropriate by the authorities of the Member State in
which the release is to be conducted.
The application must include a full risk assessment. If the
national authority gives a favourable opinion on the placing on
the market of the GMO concerned, this Member State informs the
other Member States via the Commission. If there are no
objections, the competent authority that carried out the
original evaluation grants the consent for the placing on the
market of the product. The product may then be placed on the
market throughout the European Union in conformity with any
conditions required in that consent.
If any objections are raised, a decision has to be taken at
Community level. The Commission first asks for the opinion of
its Scientific Committees composed of independent scientists,
highly qualified in the fields associated with medicine,
nutrition, toxicology, biology, chemistry, or other similar
disciplines.
If the scientific opinion is favourable, the Commission then
proposes a draft Decision to the Regulatory Committee composed
of representatives of Member States for opinion. If the
Regulatory Committee gives a favourable opinion, the Commission
adopts the Decision.
If not, the draft Decision is submitted to the Council of
Ministers for adoption by qualified majority or rejection. If
the Council does not act within 3 months, the Commission can
adopt the decision.
The revised Directive 2001/18 which comes into force in October
2002 updates and strengthens the existing rules of the risk
assessment and the decision-making process on the release of
GMOs into the environment. In particular it introduces mandatory
information to the public and general rules on mandatory
labelling and traceability at all stages of the placing on the
market.
The new Directive also foresees mandatory monitoring
requirements of long-term effects associated with the
interaction with other GMOs and the environment. Such effects
will also to be taken into account in the risk assessment
carried out prior to authorisation. First approvals for the
release of GMOs will be limited to a maximum of ten years, and
consultation of the Scientific Committee(s) becomes obligatory.
The new Directive also introduces an obligation to consult the
European Parliament on decisions to authorise the release of
GMOs and the possibility for Council of Ministers to adopt or
reject a Commission proposal for authorisation of a GMO by
qualified majority.
How many GMOs have been approved for release into the
environment?
Since Directive 90/220/EEC entered into force in October 1991,
the commercial release of 18 GMOs has been authorised in the EU
by a Commission Decision, mostly following a qualified majority
vote in the Regulatory Committee. In two cases the Commission
Decision has not yet been implemented by the Member State (see
Annex 1). Since October 1998 no further authorisations have been
granted and there are currently 12 applications pending (see
Annex 2). Some Member States have invoked Article 16, the
so-called safeguard clause, of Directive 90/220/EEC to
temporarily ban the placing on the
market of genetically modified maize and oilseed rape products
in their territories. There are currently nine ongoing Article
16 cases involving Austria, Luxembourg, France, Greece, Germany
and United Kingdom. Eight cases have been examined by the
Scientific Committee on Plants, which in all cases deemed
that the information submitted byMember States did not justify
their bans.
What are the current rules on the marketing of GM foods?
Regulation (EC) 258/97 on Novel Foods and Novel Food Ingredients
sets out rules for authorisation and labelling of novel foods
including food products containing, consisting or produced from
GMOs.
The first step of an authorisation procedure is an assessment of
an application to market a GM food product by the Member State
where the food is to be first placed on the market. In case of a
favourable opinion, this Member State informs the other Member
States via the Commission. If there are no objections against
the application, this Member State can authorise the product for
marketing in the entire EU.
If there are objections by other Member States, a decision at
Community level is required. The Commission consults the
Scientific Committees on matters relating to public health and
adopts a decision after receiving a favourable opinion from the
Regulatory Committee. Once a Decision at Community level is
required, the time frame for authorisation is necessarily
extended.
As a derogation from the full authorisation procedure, the Novel
Foods Regulation provides for a simplified procedure for foods
derived from GMOs but no longer containing GMOs which are
"substantially equivalent" to existing foods with respect to
composition, nutritional value, metabolism, intended use and the
level of undesirable substances. In such cases, the companies
only have to notify the Commission when placing a product on the
market together with either scientific justification that the
product is substantially equivalent or an opinion to the same
effect, delivered by the competent authorities of a Member
State.
How many GMOs have been approved for use in food products?
Two genetically modified plants, a variety of soybean and a
variety of maize have been authorised under Directive 90/220/EEC
prior to the entry into force of the Novel Foods Regulation, to
be on the European market for the use in food. Under the Novel
Foods Regulation no products consisting of or containing live
GMOs have so far been authorised under the full procedure.
Eleven applications concerning such products are pending at
different stages in the procedure. (Annex 3) Several products
produced from GMOs have been notified to the Commission as being
substantially equivalent (see Annex 4). The list of
notifications is published in the Official Journal of the EU
once a year.
What are the current rules on genetically modified feed and
which ones have been authorised ?
There is currently no Community legislation governing the use of
material derived from GMOs in feed. This is provided for in the
Proposal on GM food and feed, which was adopted by the
Commission on 25 July 2001. However, eight GMOs are authorised
in accordance with Directive 90/220/EEC for the purpose of use
in feed; these are four maize varieties, three rape varieties
and one soya variety. (See Annex1)
What are the current rules on genetically modified seeds?
Community legislation on seeds, notably Directive 98/95/EC,
specifies that national authorities that have agreed to the use
of a seed on their territory must notify this acceptance to the
Commission. The Commission examines the information supplied by
the Member State concerned and its compliance with the
provisions of Community seeds legislation. If such is the case,
the Commission includes the variety concerned in the "Common
Catalogue of varieties of Agricultural Plant Species" which
means the seed can be marketed throughout the EU. The seed
legislation furthermore requires that GMO
seed varieties have to be authorised in accordance with
Directive 90/220/EEC before they are included in the Common
Catalogue and marketed in the EU. If the seed is intended for
use in food, it also has to be authorised in accordance with the
Novel Foods Regulation.
Legislation on the marketing of forestry reproductive material
also requires prior authorisation of GM material in line with
the requirements of Directive 90/220. Community rules governing
the marketing of vine material in line with Directive 90/220/EEC
have also been adopted.
Further rules on growing conditions and other requirements for
purity concerning the presence of GM seeds in seed lots of
traditional varieties, as well as detailed labelling rules are
to be proposed.
How many GM seeds have been authorised?
So far only two GM seed varieties have been included in the
Common Catalogue for seed varieties which can be marketed in the
EU, after prior authorisation under Directive 90/220/EEC
(chicory for industrial purposes, authorised to be marketed for
breeding purposes only; See Annex 1). A further 18 applications
for inclusion in the Common catalogue of GM seed varieties are
currently pending (maize).
What are the rules for Medicines, Protection of workers and
Transport?
Authorisation of medicinal products for human and veterinary use
(including such derived from genetically modified organisms) is
regulated under Regulation (EEC) 2309/93 laying down Community
procedures for the authorisation and supervision of medicinal
products for human and veterinary use.
Council Directive 90/679/EEC on the protection of workers from
the risks related to exposure to biological agents at work also
regulates GMOs alongside other biological agents.
What are the current rules on labelling?
The EU recognises the consumers' right for information and
labelling as a tool to make an informed choice.
Since 1997 labelling to indicate the presence of GMOs as such or
in a product is mandatory.
The Novel Foods Regulation provides for the mandatory labelling
of foods and food ingredients which contain or consist of a GMO
without prejudice to the other labelling requirements of
Community law. The labelling requirements for foods derived from
GMO, but no longer containing GMO are more complicated and based
on the concept of equivalence(1). Council Regulation 1139/98
lays down provisions for the labelling of foods and food
ingredients derived from one maize and one soya(2) variety based
on the presence of DNA or protein resulting from genetic
modification. This criterion serves
as a model providing the rules applicable to labelling of all
foods and food ingredients derived from GMO.
In January 2000, the Commission adopted Regulation (EC) 50/2000
ensuring that also additives and flavourings have to be labelled
if DNA or protein of GMO origin is present in the final product.
Regulation (EC) 49/2000 addresses the problem of adventitious
contamination of GM material in conventional food. It introduces
a 1% de minimis threshold for DNA or protein resulting from
genetic modification below which labelling is not required, if
operators can demonstrate that they have used appropriate steps
to avoid the presence of GM material.
Genetically modified seed varieties must be labelled, in
accordance with Council Directive 98/95/EEC. The label has to
show clearly that it is a GM variety.
Currently, there is no specific Community legislation on the
labelling of GMO feed. The general labelling rules under
Directive 90/220/EEC apply. A new Novel Feed legislation will
foresee provisions for labelling.
Part B : NEW LEGISLATIVE
PROPOSALS
What are the contents of the latest proposals from European
Commission concerning traceability and labelling of GMOs?
The European Commission adopted on 25 July 2001 two legislative
proposals on GMOs. They set up a harmonised community system to
trace GMOs, introduce the labelling of GM feed, reinforce the
current labelling rules on GM food and establish a streamlined
authorisation procedure for GMOs in food and feed and their
deliberate release into the environment.
The proposals aim to put into place a stringent regulatory
framework and to close existing legal gaps. They address the
legitimate concerns of citizens, consumer organisations and
economic operators. A strict safety assessment of GMOs will
continue to assure a high level of health and environmental
protection. The labelling of all GM food and feed products will
allow consumers and farmers to decide if they want to buy food
or feed produced from a GMO, or not.
The package consists of:
Why is the Commission
proposing specific rules on traceability of GMOs?
Traceability provides the means to trace products containing or
produced from GMOs through the production and distribution
chains. The general objectives are to facilitate :
- control and verification of
labelling claims;
- targeted monitoring of
potential effects on the environment, where appropriate;
- withdrawal of products that
contain or consist of GMOs should an unforeseen risk to human
health or the environment be established;
However, whilst Directive 2001/18
includes general provisions on which a traceability system for
GMOs could be based, it neither contains a definition of
traceability for GMOs, nor does it include the objectives of
traceability or a complete approach for its implementation.
Differences and overlap between national laws, regulations and
administrative provisions concerning traceability of GMOs and
food and feed products produced from GMOs may hinder the free
movement of products and create conditions of unfair
competition. A Community Regulation based on the requirements of
Directive 2001/18/EC and laying down a harmonised framework for
traceability of such products would provide legal certainty and
a coherent approach, and thus contribute to the effective
functioning of the internal market.
Does traceability apply to GMOs and GM products only, or also
to other food products?
Traceability for certain products has existed for many years.
The proposed regulation sets specific traceability requirements
for GM products. Traceability specifically for GMOs was
introduced in general terms into Community legislation with
Directive 2001/18/EC(3) which requires that Member States ensure
traceability at all stages of the placing on the market for
GMOs. (General traceability provisions have already been laid
down in Community legislation concerning food, feed and seed.
Legislation for specific traceability scheme for beef products
has been put into place as in response to the BSE crisis
(Regulation 1760/2000/EC). The Commission Proposal for a Council
and Parliament Regulation laying down the general principles and
requirements of food law, currently under examination by the
European Parliament and the Council, establishes the principle
of traceability at all stages of the production and distribution
chain in the food and feed sectors.
What are the new rules on traceability of GMOs?
Under the rules of the proposed Regulation on traceability
business operators must transmit and retain information about
products that contain or are produced from GMOs at each stage of
the placing on the market. In particular, the requirements are
that:
- operators shall have systems
and procedures in place to identify to whom and from whom
products are made available;
- for GMOs intended for
deliberate release into the environment, operators must
transmit specified
information on the identity of the individual GMO(s) a product
contains;
- for GMOs intended for food,
feed or for processing, business operators may either transmit
the
specified information mentioned above or transmit a
declaration that the product shall only be
used as food or feed or for processing, together with the
identity of the GMO(s) that the product
may contain;
- for food and feed produced
from GMO(s) operators shall inform the next operator in the
chain that the product is produced from GMO(s);
- operators shall retain the
information for a period of 5 years and make it available to
competent
authorities on demand.
Transmission and keeping records
of this information will reduce the need for sampling and
testing of products. To facilitate a co-ordinated approach for
inspection and control by the Member States, the Commission will
develop technical guidance on sampling and testing methods prior
to the application of this proposed regulation.
How does traceability work in practice?
Traceability can be defined as the ability to trace products
through all stages of the production and distribution line.
Traceability starts with the company that develops a GMO, for
instance a genetically modified seed. This company would then
have to inform any purchaser of the seed that it is genetically
modified, together with more specified information allowing the
specific GMO to be precisely identified. The company is also
obliged to keep a register of business operators who have bought
the seed.
Equally the farmer would have to inform any purchaser of the
harvest that it is genetically modified and keep a register of
operators to whom he has made the harvest available.
The proposal covers all GMOs that have received Community
authorisation for the placing on the market, that is all
products, including food and feed, containing or consisting of
GMOs. Examples are seeds, which have been genetically modified
and bulk quantities or shipments of whole GM grain eg.soybean
and maize.
The proposal also covers food and feed which are derived from a
GMO. This includes tomato paste and ketchup produced from a GM
tomato or starch, oil or flour produced from a GM maize.
What are the cost implications for operators of the
traceability proposal?
It is difficult to estimate the exact costs of introducing
traceability specifically for GMOs and products derived from
GMOs.
Information with respect to the supplier, customer, price and
transaction date as well as the nature, source, contents and
amount of the product already accompanies the majority of
transactions. This information has also to be retained by
operators under national administrative systems, for example for
filling in VAT returns. Transmission and retention of the
information specified in the proposal could largely be
incorporated into existing systems for transactions and as such,
should not imply significant extra costs for operators.
What are the new proposed labelling rules and what is the
difference with the existing rules?
The proposal extends the current labelling provisions to all
genetically modified food or feed, irrespective of the
detectability of genetically modified DNA or protein. All food
and feed which consist of, contain or are produced from GMOs
would have to be labelled as such. The purpose is to inform
consumers and farmers about the exact nature and characteristics
of the food or feed, so that they can make informed choices.
The current GM labelling system is based on the detectability of
genetically modified DNA or protein in the final food product.
In practice this means that highly processed foodstuffs produced
from GM material, such as highly refined oils, do not need to be
labelled. The proposed labelling rules extend the labelling
requirements to all food and ingredients produced from GMOs to
allow consumers to exercise their freedom of choice.
Genetically modified feed will need to be labelled along the
same principles to give livestock farmers accurate information
on the composition and properties of feed. This will mean that a
large number of feedstuffs currently not subject to GM labelling
requirements, such as GM soy meal in feed or compound feedstuffs
and the four genetically modified feed plants authorised under
Directive 90/220/EEC will in future need to be labelled. See
also Annex 5.
Will the meat or milk of an animal fed with GM feed also be
labelled as GM?
In line with the general EU rules on labelling, the proposal
does not require labelling of products that are not food
ingredients such as processing aids. It does not require
labelling of products such as meat, milk or eggs obtained from
animals fed with genetically modified feed or treated with
genetically modified medicinal products. See also Annex 5.
How will GM food and feed in future be authorised?
Clear rules are already set out in the EU for the assessment and
authorisation of GMOs and GM-food, but the responsibilities are
currently divided between the Member States and the Community.
The Commission has proposed to replace this with a "one door one
key" procedure for the scientific assessment and authorisation
of GMOs and GM food and feed It puts in place a streamlined,
uniform and transparent Community procedure for all marketing
applications, whether they concern the GMO itself or the food
and feed products derived thereof. This means that business
operators need not request separate authorisations for use of
the GMO, and for its use in feed or in food, but that a single
risk assessment and a single authorisation are given for a GMO
and its possible uses. This will ensure that experiences such as
with Starlink maize in the US are avoided because GMOs likely to
be used as food and feed can only be authorised for both uses,
or not at all.
The scientific risk assessment will be carried out by the
European Food Authority covering both the environmental risk and
human and animal health safety assessment. Its opinion will be
made available to the public and the public will have the
possibility to make comments. On the basis of the opinion of the
European Food Authority, the Commission will draft a proposal
for granting or refusing authorisation. The proposal will, as it
is currently the case, be approved through qualified majority of
the Member States within a Regulatory Committee.
Products authorised shall be entered into a public register of
GM-food and feed. Authorisations will be granted for a period of
10 years, subject where appropriate to a post-market monitoring
plan. Authorisations are renewable for 10-year periods.
The simplified procedure for putting on the market GM-foods
which are considered to be substantially equivalent to existing
foods will be abandoned.
Will there be new rules on GM seed?
Two further proposals relating to GM seeds in seeds of
conventional varieties are to be adopted in the near future. The
first one is a Commission Directive amending the annexes of the
different seed Directives, setting additional conditions and
requirements concerning the adventitious or technically
unavoidable presence of GM seeds in seed lots of non-GM
varieties and specifying the labelling requirements of seeds of
genetically modified varieties.
At the same time a Commission Regulation on a protocol for
sampling and testing of seed lots of non-GM varieties for the
presence of GM seed will define how seed testing has to be
carried out when applying the requirements set out in the
previously mentioned Commission Directivewill be put forward.
Why is the Commission proposing to allow the presence of
traces of non-approved GMOs?
The adventitious or unintended presence of GMOs in products
placed on the market in the European Union is largely
unavoidable and can occur during cultivation, handling, storage
and transport. This situation already exists and affects
products originating both in the Community and third countries.
This is not a problem which is not unique to GMOs. In the
production of food, feed and seed, it is practically impossible
to achieve products that are 100% pure.
The present proposal acknowledges this fact and defines the
specific conditions under which a technically unavoidable
presence of unauthorised GMOs could be permitted. A number of
GMOs have already been assessed by the Scientific Committees
advising the European Commission as not posing a danger to
environment and health, but their final approval is still
pending. The proposal allows the presence of these GMOs in a
food or feed up to a maximum of 1% below which labelling and
traceability will not be enforced. This is on the basis that the
presence of such material is adventitious or technically
unavoidable and has been subject to a scientific risk assessment
by the relevant Scientific Committees or European Food
Authority, which has concluded that the material does not
present a risk for human health and the environment.
This exemption aims to solve the problem faced by operators who
have tried to avoid GMOs, but find that their products contain a
low percentage of GM material due to accidental or technically
unavoidable contamination. Current legislation on GM foods
(Regulation 1139/98, see above) already sets a threshold of 1%
for the labelling of approved GM material.
Are the new labelling rules in line with the international
trade rules?
The proposals take account of the Community's international
trade commitments and of the requirements of the Cartagena
Protocol on Biosafety with respect to obligations of importers.
A further legislative proposal setting rules concerning the
obligations of exporters and other elements of the Cartagena
Protocol is being prepared.
Will the Commission resume the authorisation process of GMOs?
The revised rules on the deliberate release of genetically
modified organisms, as adopted in February 2001 (Directive
2001/18/EC) set out effective, efficient and transparent
measures to ensure a high level of protection for human health
and the environment. The two legislative proposals put forward
in July 2001 build on the principles of this Directive and
provide a regulatory framework for labelling and
traceability. Together, this package of measures aims to address
the concerns of Member States and to build consumer confidence
in the authorisation of GM products. The revised Directive and
the adoption of the two proposals for Regulations are expected
to pave the way for a resumption of GM authorisations in the
European Union.
Annex 1
GMO PRODUCTS APPROVED UNDER DIRECTIVE 90/220/EEC as of March 2001
| Product |
Notifier |
Date of Commission Decision(4)
/ Member State Consent(5) |
| 1. Vaccine against Aujeszky's disease |
Vemie Veterinär Chemie GmbH |
18.12.92 |
| 2. Vaccine against rabies |
Rhône-Mêrieux C/B/92/B28 & C/F/93/03-02 |
19.10.93 |
| 3. Tobacco tolerant to bromoxynil |
SEITA C/F/93/08-02 |
08.06.94 |
| 4. Vaccine against Aujeszky's disease (further uses)(6) |
Vemie Veterinär Chemie GmbH
C/D/92/I-1 |
18.07.94 |
| 5. Male sterile swede rape resistant to glufosinate ammonium (MS1,
RF1) Uses : breeding activities |
Plant Genetic Systems C/UK/94/M1/1 |
06.02.96 |
| 6. Soybeans tolerant to glyphosate Uses : import and processing |
Monsanto C/UK/94/M3/1 |
03.04.96 |
| 7. Male sterile chicory tolerant to glufosinate ammonium Uses : breeding
activities |
Bejo-Zaden BV C/NL/94/25 |
20.05.96 |
| 8. Bt-maize tolerant to glufosinate ammonium (Bt-176) |
Ciba-Geigy C/F/94/11-03 |
23.01.97 |
| 9. Male sterile swede rape tolerant to glufosinate ammonium (MS1, RF1)(7) |
Plant Genetic Systems C/F/95/05/01/A |
06.06.97 |
|
| Product |
Notifier |
Date of Commission Decision(8)
/ Member State Consent(9) |
| 10. Male sterile swede rape tolerant to glufosinate ammonium (MS1,
RF2)(10) |
Plant Genetic Systems C/F/95/05/01/B |
06.06.97 |
| 11. Test kit to detect antibiotic residues in milk |
Valio Oy C/F1/96-1NA |
14.07.97 |
| 12. Carnation lines with modified flower colour |
Florigene C/NL/96/14 |
01.12.97
(MS consent) |
| 13. Swede rape tolerant to glufosinate ammonium (Topas 19/2) Uses :
import and processing |
AgrEvo C/UK/95/M5/1 |
22.04.98 |
| 14. Maize tolerant to glufosinate ammonium (T25) |
AgrEvo C/F/95/12/07 |
22.04.98 |
| 15. Maize expressing the Bt cryIA(b) gene (MON 810) |
Monsanto C/F/95/12-02 |
22.04.98 |
| 16. Maize tolerant to glufosinate ammonium and expressing the Bt cryIA(b)
gene (Bt-11) Uses : import and processing |
Novartis (formerly Northrup King) C/UK/96/M4/1 |
22.04.98 |
| 17. Carnation lines with improved vase life |
Florigene C/NL/97/12 |
20.10.98
(MS consent) |
| 18. Carnation lines with modified flower colour |
Florigene C/NL/97/13 |
20.10.98
(MS consent) |
Annex 2
GMO PRODUCTS - PENDING APPROVAL UNDER DIRECTIVE 90/220/EEC As of October 2001
|
Product notification details |
Company |
Maize expressing the Bt cryIA(b) gene (MON 809) from
France (C/F/95/12-01/B) Received by the Commission: 06.08.96
Favourable opinion of EU Scientific Committee 19.05.98
Uses: as any other maize |
Pioneer |
Male sterile chicory(11) from the Netherlands (C/NL/94/25/A) Received by the Commission: 20.09.96
Favourable opinion of EU Scientific Committee 18.12.98
Uses: food and feed |
Bejo-Zaden BV |
| Swede rape tolerant to glufosinate ammonium (FALCON GS40/90) from
Germany (C/DE/96/5) Received by the Commission: 25.11.96
Uses: as any other swede rape |
AgrEvo GmbH |
Male sterile swede rape tolerant to glufosinate ammonium (MS8, RF3) from Belgium (C/BE/96/01) Received by the Commission: 16.01.97
Favourable opinion of EU Scientific Committee 19.05.98
Uses: as any other swede rape |
Plant Genetic Systems |
Fodder beet tolerant to glyphosate from Denmark (C/DK/97/01)
Received by the Commission: 09.10.97
Favourable opinion of EU Scientific Committee 23.06.98
Uses: production of seeds and roots, animal feed |
DLF-Trifolium, Monsanto and Danisco Seed |
Cotton expressing the Bt cryIA(c) gene (line 531) from
Spain (C/ES/96/02) Received by the Commission: 24.11.97
Favourable opinion of EU Scientific Committee 14.07.98
Uses: as any other cotton |
Monsanto |
Cotton tolerant to herbicide (line 1445) from Spain (C/ES/97/01)
Received by the Commission: 24.11.97
Favourable opinion of EU Scientific Committee 14.07.98
Uses: as any other cotton |
Monsanto |
| Potato with altered starch composition from Sweden (C/SE/96/3501)
Received by the Commission: 20.05.98 uses: as any other starch potato |
AMYLOGENE |
Swede rape tolerant to glufosinate ammonium (Liberator) from
Germany (C/DE/98/6) Received by the Commission: 29.10.98
Favourable opinion of EU Scientific Committee 30.11.00
Uses: as any other swede rape |
AgrEvo GmbH |
Maize tolerant to glufosinate ammonium and expressing the Bt cryIA(b)
gene (Bt-11)(12)
from France (C/F/96/05-10) and Spain (C/ES/98/02) Received by the Commission:
12.04.99 and 03.05.99 respectively
Favourable opinion of EU Scientific Committee 30.11.00
Uses : cultivation |
Novartis |
Maize tolerant to glufosinate ammonium and expressing the Bt cryIA(b)
gene (T25 + MON810)(13) from the Netherlands (C/NL/98/08) Received by the Commission: 29.04.99
Favourable opinion of EU Scientific Committee 06.06.00
Uses: as any other maize |
Pioneer |
12. Maize tolerant to glyphosate (GA21) from Spain (C/ES/98/01)
Received by the Commission: 20.05.99
Favourable opinion of EU Scientific Committee 22.09.00
Uses: as any other maize |
Monsanto |
|
|
|
Annex 3
Pending applications under Regulation (EC) N° 258/97 of the European
Parliament and of the Council
|
Applicant |
Description of Food or Food Ingredient |
Initial Assessment Carried out by |
Application
Date |
Status
By June 2002 |
| 1 |
Bejo-Zaden
P.O.Box 50
NL 1749 Warmenhuizen |
Transgenic Radicchio rosso with male sterility |
The Provisional Committee for the safety evaluation of novel foods
(VcVnv) (NL) |
8 April 1998 |
Under assessment by the Scientific Committee on Food (SCF). |
| 2 |
Bejo-Zaden
P.O.Box 50
NL 1749 Warmenhuizen |
Transgenic Green hearted Chicoree with male sterility |
The Provisional Committee for the safety evaluation of novel foods
(VcVnv) (NL) |
8 April 1998 |
Under assessment by the SCF |
| 3 |
E.I. DuPont Nemours & Co.
Agricultural Enterprise
Optimum Quality Grains L.L.C., Registration and Regulatory Affairs Europe
Ebertstr. 4, D 07743 Jena |
High Oleic Soybean Sublines derived from transformation event 260-05 |
The Provisional Committee for the safety evaluation of novel foods
(VcVnv) (NL) |
25 July 1998 |
Initial assessment report pending |
| 4 |
Monsanto Services International S.A.
Ave. de Tervuren 270 272
B 1150 Bruxelles |
Roundup Ready Maize line GA21 |
The Provisional Committee for the safety evaluation of novel foods
(VcVnv) |
24 July 1998 |
SCF opinion of 27 February 2002 |
| 5 |
Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B 9000 Gent |
Liberty Link Soybean by AgrEvo |
Bioveiligheidsraad (B) |
2 February 1999 |
Initial assessment report pending. |
| 6 |
Novartis Seeds AG
Basel, CH 4002 Basel |
Bt11 sweet maize |
Gezondheidsraad (NL) |
11 February 1999 |
SCF opinion of 13 March 2002 |
| 7 |
Monsanto Services International S.A.
Avenue de Tervuren 270-272
B 1150 Belgium |
MaisGard/RoundupReady |
Gezondheidsraad (NL) |
16 March 2000 |
Initial assessment report pending |
| 8 |
Pioneer Overseas Corporation
Avenue Tedesco, 7
B 1160 Brussels |
Conventionally derived crosses between genetically modified maize lines
T25 and MON810 (T25 X MON810) |
Gezondheidsraad (NL) |
20 April 2000 |
Initial assessment report pending |
| 9 |
Monsanto Europe S.A.
270 272 Avenue Tervuren
B 1150 Brussels and;
Novartis Seeds AB, Box 302
S 261 23 Landskrona |
Foods and food ingredients derived from Roundup Ready Sugar Beet |
Gezondheidsraad (NL) |
|
Initial assessment report pending |
| 10 |
Pioneer Overseas Corporation
Avenue Tedesco 7
B 1160 Brussels |
Food products of genetically modified B.t. CRY1F Maize line
1507 |
Gezondheidsraad (NL) |
26 February 2001 |
Initial assessment report pending |
| 11 |
Monsanto Services International S.A.
Ave. de Tervuren 270 272
B 1150 Bruxelles |
Roundup Ready maize line NK603 |
Gezondheidsraad (NL) |
June 2001 |
Initial assessment report pending |
Annex 4
Notifications Pursuant to Article 5 of Regulation (EC) N° 258/97
of the European Parliament and of the Council
|
Applicant |
Description of
Food or Food Ingredient |
Scientific Evidence |
Notification |
Transmission
to Member States |
| 1 |
AgrEvo UK Limited
Chesterford Park
Saffron Walden
UK - Essex CB10 1XL |
Processed oil from genetically modified canola seed, transformation
event TOPAS 19/2 and all conventional crossed |
"Report on oil from a genetically modified (GM) glufosinate ammonium
tolerant oilseed rape"
(ACNFP)*(14) |
9 June 1997 |
24 June 1997 |
| 2a |
Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B 9000 Gent |
Processed oil from genetically modified oilseed rape seed derived from:
i) male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses;
ii) fertility restorer RF2Bn (B94-2) oilseed rape line and all conventional
crosses; iii) hybrid combination MS1XRF2 |
"Report on oil from a fertility restorer line for use in a hybrid breeding
programme for genetically modified (GM) oilseed rape" (ACNFP)* |
10 June 1997 |
24 June 1997
again
28 July 1998 |
| 2b |
Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B - 9000 Gent |
Processed oil from genetically modified oilseed rape seed derived from:
i) male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses;
ii) fertility restorer RF1Bn (B93-101) oilseed rape line and all conventional
crosses; iii) hybrid combination MS1XRF1 |
"Report on oil from a fertility restorer line for use in a hybrid breeding
programme for genetically modified (GM) oilseed rape" (ACNFP)*;
and
"Report on oil from genetically modified oilseed rape" (ACNFP)* |
10 June 1997 |
24 June 1997
again
28 July 1998 |
| 3 |
Monsanto Services International S.A
Avenue de Tervuren 270-272
B - 1150 Brussels |
Refined oil from glyphosate tolerant oilseed rape line GT73 |
"Report on oil from genetically modified (GM) glyphosate tolerant oilseed
rape" (ACNFP)* |
10 November 1997 |
21 November 1997 |
| 4 |
Monsanto Services International S.A
Avenue de Tervuren 270-272
B - 1150 Brussels |
Food and food ingredients produced from maize flour, maize gluten,
maize semolina, maize starch, maize glucose and maize oil derived from
the progeny of maize line MON 810 |
"Report on processed products from genetically modified (GM) insect
protected maize" (ACNFP)* |
10 December 1997 |
6 February 1998 |
| 5 |
AgrEvo France S.A.
Les Algorithmes
Bâtiment Thalès
Saint Aubin
F - 91197 Gif-sur-Yvette Cedex |
i) Starch and all its derivatives; ii) crude and refined oil; iii)
all heat-processed or fermented products obtained from hominys, grits and
flour (dry milled fragments) obtained from the genetically modified maize,
tolerant to glufosinate ammonium, transformation event T25 and all the
varieties derived from |
"Report on processed products from genetically modified (GM) glufosinate
ammonium tolerant maize" (ACNFP)* |
12 January 1998 |
6 February 1998 |
| 6 |
Novartis Seeds AG
Schwarzwaldallee 215
CH - 4058 Basel |
Food and food ingredient products derived from the original transformant
Bt11 crossed with the Northrup King Company inbred line #2044 (maize),
as well as from any inbred and hybrid lines derived from it and containing
the introduced genes |
ACNFP* Report on grain from maize genetically modified for
insect resistance |
30 January 1998 |
6 February 1998 |
| 7 |
Pioneer Overseas Corporation
Avenue Tedesco, 7
B 1160 Brussels |
Novel foods and novel food ingredients produced from gentically modified
maize line MON 809 |
ACNFP* Report on genetically modified (GM) insect protected
maize Pioneer Hi-bred International line MON 809 |
14 October 1998 |
23 October 1998 |
| 8 |
Hoechst Schering,
AgrEvo GmbH
Industriepark Hoechst
AgrEvo-Haus K 607
D 65926 Frankfurt am Main |
Processed oil from genetically modified oilseed rape derived from Falcon
GS 40/90 |
BgVV*(15)*
Stellungnahme zur wesentlichen Gleichwertigkeit des aus der transgenen,
Glufosinat-toleranten Rapssorte Falcon GS/40/90 gewonnenen raffinierten
Speiseöls |
21 October 1999 |
8/9 November 1999 |
| 9 |
Hoechst Schering,
AgrEvo GmbH
Industriepark Hoechst
AgrEvo-Haus K 607
D 65926 Frankfurt am Main |
Processed oil from genetically modified oilseed rape derived from Liberator
L62 |
BgVV** Stellungnahme zur wesentlichen Gleichwertigkeit des
aus der transgenen, Glufosinat-toleranten Rapssorte Liberator pHoe6/Ac
gewonnenen raffinierten Speiseöls |
21 October 1999 |
8/9 November 1999 |
| 10 |
Plant Genetic Systems N.V.
Jozef Plateaustraat 22
B 9000 Gent |
Processed oil from genetically modified oilseed rape derived from:
the male sterile MS8 (DBN 230-0028) oilseed rape line and all conventional
crosses; the fertility restorer RF (DBN212-0005) oilseed rape line and
all conventional crosses; the hybrid combination MS8 x RF3 |
BgVV** Stellungnahme zur wesentlichen Gleichwertigkeit des
aus der transgenen, Glufosinat-toleranten Rapssorte MS8/RF3 gewonnenen,
raffinierten Speiseöls |
21 October 1999 |
8/9 November 1999 |
| 11 |
F. Hoffman La Roche Ltd.
Vitamins & Fine Chemicals
Regulatory Affairs
Bldg 241/283
CH 4070 Basel |
Riboflavin from Bacillus subtilis as nutrient |
ACNFP* Report on Riboflavin from fermentation using genetically
modified (GM) Bacillus subtilis |
20 March 2000 |
26 April 2000 |
Annex 5
Labelling of GM-Food and GM-Feed Examples (16)
| GMO-type |
EXAMPLE |
Labelling
Required
at
present |
Labelling required
in future |
| GM plant |
Chicory(17) |
Yes |
Yes |
| GM seed |
Maize seeds |
Yes |
Yes |
| GM food |
Maize, Soybean sprouts, Tomato |
Yes |
Yes |
| Food |
Maize flour (18) |
Yes |
Yes |
| produced |
Highly refined maize oil, soybean oil, rape seed oil (19) |
No |
Yes |
| from GMOs |
Glucose syrup produced from maize starch \* MERGEFORMAT 17 |
No |
Yes |
| Food from animals fed on GM feed |
Eggs, meat, milk |
No |
No |
| Food produced with the help of a GM enzyme |
bakery products produced with the help of amylase |
No |
No |
| Food additive/flavouring produced from GMOs |
Highly filtered lecithin extracted from GM soybeans used in chocolate
\* MERGEFORMAT 17 |
No |
Yes |
| GM Feed |
Maize
(20) |
Yes |
Yes |
| Feed produced from a GMO |
Corn gluten feed, Soybean meal |
No |
Yes |
| Feed additive produced from a GMO |
Vitamin B2 (riboflavin) |
No |
Yes |
(1)
This means that if a characteristic or property (composition, nutritional
value or nutritional effects, intended use) renders a food or food ingredient
no longer equivalent to an existing counterpart, it has to be labelled
indicating the method (i.e. genetic modification) by which the characteristic
or property was obtained.
(2)
These varieties were approved before the entering into force of the Novel
Foods Regulation under Directive 90/220/EEC on the deliberate release into
the environment of genetically modified organisms
(3)OJ
L 106, 17.4.2001, p.1.
(4)
where objections were raised by Member State authorities
(5)
in the absence of objections by Member State authorities
(6)
linked to item 1 (same product, further uses)
(7)
linked to item 5 (same product, further uses)
(8)
where objections were raised by Member State authorities
(9)
in the absence of objections by Member State authorities
(10)
this product is the result of a different transformation event to that
of No. 9
(11)
This is the same product as No. 7 on the list of approved GMOs, which was
restricted to breeding activities.
(12)
This is the same product as No. 16 on the list of approved GMOs, which
was restricted to import and processing
(13)
This product is obtained from conventionally derived crosses between Nos.
14 and 15 on the list of approved GMOs
(14)*
ACNFPAdvisory Committee on Novel Foods and Processes (UK)
(15)**
BgVVBundesamt für gesundheitlichen Verbraucherschutz und Veterinärmedizin
(D)
(16)
The examples include foods which have not been authorised for marketing
in the EU. See Annex II for a list of products which can legally be marketed
in the EU.
(17)
One chicory has been approved for breeding purposes under Directive 90/220/EC,
but not for food use
(18)
DNA or protein of GM origin detectable in the final product.
(19)
DNA or protein of GM origin not detectable in the final product.
(20)
The current labelling rules entered into force in 1997, and do not include
four GMOs approved prior to that date.
|
