GENTECH archive 8.96-97


FOEE Mailout

The current Mailout of FRIENDS OF THE EARTH EUROPE contains many 
articles worth to read but regarding of the size (53 kbyte) I will
provide you only with an excerpt. You can retrieve the whole MAILOUT
with a message to and a subject line
containing "archive get docu/foee297.txt". 


 Mailout Vol. 3 (1997), Issue 1, 31st January 1997

 In this issue :
 - deregulation of Directive 220
 - genetically modified cottonseed oil
 - vote on the Novel Food Regulation
 - Ciba Geigys maize runs into more problems
 - Austria bans Ciba s g.e. maize
 - scientific committees  reports on g.e. maize
 - GMOs released under simplified procedure
 - the new Patents Directive proposal
 - deregulation of Directive 219
 - Avoparcin is banned in the EU
 - salmon growth hormones 
 - GMOs awaiting market approval


  Although the Commission granted authorization, on 18th December
1996, for the placing on the market of Ciba Geigy s genetically
modified maize, different factors have developed over recent weeks
which are hampering the market release.  Firstly, there was quite a
significant delay in the Commission officially informing the French
government that the market release had been approved.  On 9th January,
a Commission spokesman said that  notification is imminent ,
indicating that imports of the genetech maize into the EU could then
go ahead.  However, it was only as recently as 27th January - more
than five weeks after the decision was taken - that a Commission
spokesman indicated that France had finally been officially notified,
although he gave no explanation for the delay.  

  In the meantime, no sooner was the decision for authorization of
market release taken by the Commission than the French government
announced that it would not allow the import of genetech maize from
the U.S. unless the product was labelled.  This is quite paradoxical
since France was the notifying Member State which originally requested
authorization for the placing on the market, and which continued to
support the proposal unwaveringly during its troubled passage through
the Council and the Commission!  (It was only due to France s positive
vote at the meeting of the Environment Council in June 96 - all the
other Ministers voted against with one abstention - that the decision
was passed back to the Commission.)  At the end of December, however,
the French Agriculture Minister, Philippe Vasseur, issued a statement
saying that he would not authorize the release of genetech maize as
long as the labelling issue had not been settled.  Furthermore, French
farmers will not be allowed to grow genetech maize until the Ministry
clears it release on the French market, the statement said.  The
French demands for labelling were made in connection with remarks made
by Environment Commissioner Ritt Bjerregaard, on the day that
authorization was announced, that better labelling was desirable and
that a proposal in this regard would be put forward under the review
of Directive 220.  France has indicated that if new EU labelling
regulations are not forthcoming soon, it will draft its own labelling
rules but, either way, this could be quite a lengthy process.

  The outcome of the situation then is that until such time as France
- the country which notified request for market release in the first
place - has given the go-ahead on its home territory, the genetech
maize remains, in effect, banned in all other EU Member States.  Not
unexpectedly, this has displeased U.S. exporters and there are noises
from Washington warning of another transatlantic trade dispute.
During January, it was reported that several shipments of genetech
maize from the U.S. had already been impounded by French customs


  In another interesting development, the Belgian paper  Le Soir
published a fierce attack on the Commission on Monday, 27th January -
a front page article and nearly one full inner page.  In particular,
the articles are very critical of the way the European Commissioners
reached their decision, and of the reports of the three scientific
committees which were instrumental in the decision-making.

In this connection, at their daily news briefing with reporters on
29.01.97, a Commission spokesman acknowledged, in reference to the  Le
Soir  articles, that not everybody is happy with the decision to
authorize Ciba s maize and indicated that the reports of the three
scientific committees were freely available on request from his
office.  Copies of the reports were duly provided to the FoEE Biotech
Programme within the next 24 hours, which is interesting inasmuch as
our previous request to the biotechnology unit of DG XI asking for
copies of these reports has still not been answered.  

The decision was commercially motivated

  In it s report on the minutes of Commissioner s meeting of 18th
December, -- from which it is clear that some Commissioners such as
Bangemann, Brittan and Flynn strongly supported market release
(Brittan quote:  it will facilitate relations with the United States
unquote, Flynn stressing the importance of biotechnology to the
economic and employment sector, and Bangemann and Brittan seemingly
unwilling to push for labelling due to fears of conflict with the WTO)
--  Le Soir  prints the text of a footnote which Commissioner Emma
Bonino (Consumer Affairs, Fisheries, and Humanitarian Affairs)
requested be annexed to the minutes.  It reads as follows (translation
from the French):  While taking account of the findings of the three
scientific committees which aimed to exclude the dangers to human
health based on the information currently available, I regret that the
College (of Commissioners) has taken a decision which is so sensitive
to public opinion under the pressure and the urgency linked to the
problem of the importation of significant stocks of maize from the
United States.  I think that deeper reflection could have been
undertaken to ensure full consideration of the concerns of consumers
and their desire for transparency.  In particular, I would have liked
the Commission to clearly request the Member States, by way of a
recommendation, to carry out necessary monitoring on the mid- and
long-term effects of genetically modified maize while ensuring, to the
extent possible, adequate information for the consumer . 

Concerning the reports of the three scientific committees (see
separate article in this Mailout), the  Le Soir  article is scathing.
The author says that these reports make  stupefying  reading and that
they are extremely vague and brief, using phrases such as  almost
negligible risks  for animal health,  improbable  in connection with
allergies,  remote  with regard to transfer of antibiotic resistance.
Le Soir  also publishes an internal note emanating from the
Commissioners  Chefs de Cabinet in the days before the decision was
taken:  The maize originating from across the Atlantic is now being
stocked in EU ports.  This will put very heavy pressure on the Union
which is requested to take a decision as soon as possible, for fear of
facing actions for damage and interest.  (GL with thanks to Andre
Riche of  Le Soir ) 


After the Commission announced in December that it would grant market
approval to Ciba Geigy s hotly disputed transgenic corn, the Austrian
government immediately stated that Austria will use Article 16 of the
Directive 90/220/EEC to stop the sale and use of this maize on Austria
s territory.  Neither the Austrian Health Ministry and the Environment
Ministry are convinced about the safety of the product - even if three
Scientific Committees of the Commission say otherwise. 

  Using the famous Article 16 means, in effect, that the market
approval of the maize will once again have to be examined by the 15
member states (and not only the Commission s totally undemocratic and
untransparent committees).  The Competent Authorities of all Member
States will, within 3 months, have to come to a conclusion whether
they let Austria go ahead with its national prohibition or not.  In
the first case, the maize will not be allowed onto Austria s market.
However, if the Competent Authorities (of the so-called  Article 21
Committee ) vote against Austria, then the maize will also be allowed
to be sold in Austria.  

In order to come to a decision, the Committee has to vote by a
qualified majority.  Since already in April last year, when the maize
was first on their agenda, the experts could not agree to let it pass,
the chances are high that the experts will let Austria its own way and
ban the maize.  Denmark, Sweden and Luxembourg have already said that
they might consider joining ranks with Austria.  In addition, some
other, larger countries, such as the UK may also remain should firm in
their criticism of the corn.  Should the Article 21 Committee find no
conclusion (as was the situation last April), the whole dossier will
have to go to back to the Council once again.

  In short: the story of the maize is not over yet ......

(Thomas Schweiger, Global 2000)


 On March 16, 1995 the Commission received a notification by the
company Ciba-Geigy concerning the placing on the market of genetically
modified maize, forwarded by the French Competent Authorities.  On
April 11, 1996 the Regulatory Committee foreseen by Article 21 of the
deliberate release Directive 90/220/EEC failed to deliver an opinion
on the measures proposed by the Commission.  As reported in Mailout
Vol. 2 N  4, the Environment Ministers rejected on 25th June a
proposal to authorize the placing on the market of Ciba Geigy s
genetically modified maize and instead asked the European Commission
to reconsider the file.  Only one country - France - supported the
Commission s proposal, while 13 Member States were opposed, with
Germany abstaining. 

  On 26th July the Commission issued a press release indicating that
the scientific basis of the proposal to market this genetically
modified maize would be further assessed by three scientific
committees established at Community level.  The three committees
involved were the:   Scientific Committee for Food (SCF), Scientific
Committee for Animal Nutrition (SCAN), Scientific Committee for

  All three were been requested to give their opinion on the
scientific basis of the proposal, especially in respect to the
assessment of the effects on human health and on the environment of
the release of genetically modified maize (Zea mays L.) containing the
Bt-endotoxine gene CRYIA(b) (mediating an insect tolerance), the
glufosinate ammonium resistance gene bar (coding for the protein
phosphinothricin acetyl transferase (PAT); mediating a herbicide
tolerance) and the (non-expressed) TEM1 s-lactamase gene bla
(mediating a tolerance to the antibiotic ampicillin).

At the meeting of the Environment Council in Luxembourg on 15th
October, Commissioner Bjerregaard, informed Environment Ministers of
the state of play  and that the three committees had embarked on an
in-depth examination of this dossier.  The topic was back on the
agenda again for the Environment Ministers during the Council meeting
on Monday, 9th December.  The Commission finally decided on 18th
December in favour of placing on the market the genetically modified
maize, based on the positive assessment of the three Committees,
delivered on 9 and 13 December 1996.  The arguments of the Committees
can be summarised as follows (NB: the single text passages have been
quoted directly from the reports):

Toxicity :

The CRYIA (b) toxin has a long history of use against insect larvae
and has also been shown not to be harmful when ingested by higher
animals.  The native CRYIA (b) Protein has been tested for acute
toxicity and no mortality has been reported to 5 g per kg body weight
in mice.  In the plant kernels itself, the protein is only expressed
at a level of 5 ppb (parts per billion).  The protein itself is
rapidly degraded in vitro in simulated gastric fluid.

The native PAT protein has also been tested for acute toxicity in mice
and no mortality has been reported to 5g per kg body weight in mice.

Allergenicity :

  Allergic effects are not be expected because the sequence of the
CRYIA (b) and of the PAT protein do not show homologies with known
allergens.  Moreover, the proteins appear to be readily degraded by
simulated gastric fluid in vitro.  (NB: The committees had to argue in
this  indirect way of proof  because existing scientific methods are
not able at the moment to exactly assess the allergic potential of a
novel protein in advance.)

Concerns about the antibiotic :

There is no evidence that genes from plants have been ever transferred
under natural conditions to bacteria.  In a separate expert meeting,
several questions relating to antibiotics were discussed and the
committees concluded from the discussion that there are no serious
concerns related to the use of antibiotics and that degeneration of
DNA through processing of maize and the enzymatic decomposition of DNA
in the gastrointestinal tract makes the residual amount of intact DNA
which could contain a gene very small.  Furthermore, the transfer rate
is very small and even if a transfer would take place, it would have
no detectable additional effect, as the bla gene mediating an
ampicillin resistance is already widely spread in the human
gastrointestinal tract.  The used pUC TEM1 s-lactamase is, in
addition, not capable to inactivate the newer generation of
penicillins used in humane medicine.  The TEM1 s-lactamase has a very
narrow spectrum of resistance compared to variants of E.coli strains
living in the human gut.

Nevertheless the SCF was conscious of the general question of the use
of genes coding for antibiotic resistance and proposes to scrutinise
the future needs and application of marker genes.

Although differences between the concentration of other components of
toxicological or nutritional relevance in the GM plant and the parent
plant were statistically significant in some instances, the measured
levels were still within the published reference biological variation
of maize.  (NB: This quite broad definition of  biological variation
clearly shows that for the implementation of the Novel Food
Regulation, this expression had to be defined more precisely.
Otherwise, it could be possible that, for example, the discovery of a
new variety of maize in the High Andes of Peru, with a extremely high
or low level of a specific substance could be taken as a reference too.

  The PAT gene is only used as a marker gene.  The direct use of
glufosinate-ammonium is not planned and has not so far been authorized
under Directive 91/414/EEC for direct application.

SCF : Ciba s maize is  substantially equivalent  :

  From a political point of view, the report of the SCF is of special
interest because the SCF expressed the position, that  the transgenic
maize is substantially equivalent to the corresponding non-transgenic
maize  and that the  composition of the transgenic maize is within the
known biological variation .  In case the maize would have been
authorized under the Novel Food Regulation (NFR), this would have
resulted in:   

 (a)	a simplified notification procedure according to Art. 5 of the
Regulation, and (b)	no labelling, because according to Art 8(1)a,
sentence 3 of the NFR, the novel food will be labelled only in case it
is not identical to a conventional food.  Identical, however, is
defined as  a food which can be differed by analytical methods from a
conventional one, taking into account the natural biological variation

It is, however, unclear why the SCF can argue that the composition is
within the biological variation, when in the same report the Committee
agreed on the fact that neither the CRYIA nor the PAT nor the
lactamase gene is normally expressed in plants.  (JK)