APPENDIX 23
Supplementary memorandum submitted by
Professor J M Bainbridge, Chairman of the Advisory Committee on
Novel Foods and Processes (R 36)
In response to your request for further data
I have pleasure in submitting—
1. Details of approvals of GM Foods by ACNFP
prior to September 1997.
2. Some examples of outstanding applications
where further information has been requested for European clearance
is awaited.
(a) GM Tomato Processed Products—Approval
by ACNFP awaiting European clearance.
(b) Insect Protected GM Cottonseed (line
531)—insufficient data provided to ACNFP.
(c) GM Radicchio rosso and green hearted
chicory (UK objected awaiting European ruling).
1. APPLICATIONS
TO ACNFP UNDER
PREVIOUS VOLUNTARY
SCHEME FOR
SAFETY ASSESSMENTS
OF NOVEL
FOODS
The following items form part of the list submitted
to the European Commission in March 1997, which named all novel
foods that had been considered in the UK prior to that time. (Ref
ACNFP Annual Report 1996—p 150-151).
| Product | Approval Date
|
| GM Bakers Yeast | March 1990
|
| * Chymosin I, II, III | January 1991, April 1991, March 1992
|
| GM Brewers yeast | February 1994
|
| * GM Soya (glyphosate resistant) | February 1995
|
| Oil from GM oilseed rape (fertility restorer line) (male sterile line)
| February 1995 |
| * Paste from GM tomato | February 1995 (extension February 1996)
|
| Oil from GM glufosinate-ammonium tolerant rape
| May 1995 |
| Oil from GM Oilseed rape (2nd fertility restorer line)
| September 1995 |
| Oil from GM oilseed rape (glyphosate tolerant)
| February 1996 |
| Insect resistant GM maize—processed food products
| May 1996 |
| Glufosinate-tolerant GM maize | February 1997
|
| Insect resistant GM maize | February 1997
|
| Herbicide tolerant GM maize | February 1997
|
| Herbicide GM cottonseed | February 1997
|
| Herbicide tolerant and insect resistant GM maize
| February 1997 |
* Products known to have been marketed in UK prior to May
1997. Inclusion in approval list does not imply that products
have actually been sold.
Where applications were submitted to the ACNFP prior to 15
May 1997 but their evaluation had not been completed, the committee
provided advice on some aspects of these submissions (ACNFP Annual
Report 1997—Section 2) but was unable to provide a final
opinion until an application was received under the Novel Food
Regulation.
If a product had been previously cleared for food use but
not marketed within the EU before May 1997 the product required
reassessment under the Novel Food Regulation. Where products had
been approved under the voluntary safety assessment scheme and
do not require reassessment under the Novel Food Regulation (258/97)
they are still subject to provisions of the UK Food Safety Act
(1990).
2. EXAMPLES OF
PENDING APPLICATION
(a) Tomato paste from GM tomatoes has been on sale since
Feburary 1996 but not all of the processed products (peeled and
comminuted) had been on sale prior to May 1997. Therefore in 1998
the company submitted a full application. The committee considered
detailed information relating to the modification procedure and
were satisfied of no intentional change to molecular level, of
the stability of the inserted genetic material over several generations
and unchanged compositional analysis compared to non-GM counterparts.
Also the data clearly indicated that the processing totally degraded
the gene and its protein. Labelling recommendations were made
in accordance with Article 8 of 258/97. The committee's report
(ref Appendix II ACNFP Annual Report 1998) was forwarded to other
member states. However, objections were raised to the initial
assessment the European commission subsequently requested advice
from scientific committee for food (Application dated 3 March
1998)—SCF has completed its assessment and concluded that
the product is safer than the conventional counterpart.
(b) Insect protected GM cottonseed. (Line 531).
A submission, initially received in 1997 sought an opinion
on substantial equivalence of processed products (oil and linters)
denied from a line of insect resistant GM cotton. The company
stated that processing destroyed both intact protein and DNA.
The company was asked for further data to demonstrate their absence
(1997 Annual Report page 12).
Further information was supplied. It was stated that the
linters would not be used as a food but as the source for the
production of an additive (hence would need to be assessed outside
of the Novel Food Regulation but in accordance with the community
legislation on additives).
The data relating to the oil was considered but was found
to be inadequate in terms of the genetic data, the analytical
data to confirm absence of the novel gene or its protein product
in the refined oil and the compositional analyses used. In the
absence of this information no decision could be reached by ACNFP.
(c) GM radicchio rosso and green hearted chicory.
Both of these were submitted to the Netherlands competent
authority for approval. Previously ACNFP had considered the safety
of Radicchio rosso under the voluntary scheme and had requested
extra compositional data. Hence the UK objected to a marketing
consent under the EC Deliberate release directive (90/220/EC).
Extra information was received but was insufficient to alleviate
concerns about possible unintended secondary effects (on phenotype
and composition) arising from the genetic modification. A marker
gene encoding resistance to streptomycin and spectinomycin used
in the genetic manipulation was claimed to be absent the data
did not demonstrate this clearly. Futhermore the GM variety was
not comparable to the non-GM in the analysis of sesquiterpene
lactones, amino acids or biogenic amines. Nor did the application
or the Dutch CA address labelling of the products. These concerns
were forwarded to the commission (Initial application date 8 April
1998).
10 Janauary 2000
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