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Dáil Éireann debate -
Tuesday, 2 Mar 1999

Vol. 501 No. 3

Written Answers. - Food Ingredients.

John Gormley

Question:

219 Mr. Gormley asked the Minister for Health and Children if he will report on the progress of the Food Safety Authority of Ireland's scientific committee's sub-committee on GMO and novel foods; when the committee will report to him; if a report will be published; and if he will make a statement on the matter. [5771/99]

John Gormley

Question:

239 Mr. Gormley asked the Minister for Health and Children the progress, if any, of the sub-committee on GMO and novel foods; when he will receive the report from the committee; and if he will make a statement on the matter. [6041/99]

I propose to take Questions Nos. 219 and 239 together.

The GMO and novel food sub-committee was originally set up as a working group under the auspices of the Food Safety Advisory board and held its first meeting on 14 November 1996. This sub-committee advises my Department on an ongoing basis on issues in the area of genetic modification of foodstuffs. The sub-committee also affords a forum for the exchange of expert scientific opinion and advice on this new technology and its application to food. The work of the sub-committee is ongoing commensurate with developments in the area of genetic moficiation.

The GMO and novel foods sub-committee acts as the assessment body for applications made under Regulation (EC) No. 258/97 on novel foods and novel food ingredients. To date, no application for the placing of a novel food on the Irish market has been made to my Department as the Irish competent authority although the sub-committee has commented on a number of applications which have been made to other member states.

The committee also comments on the human health aspects of applications made under Directive 90/220/EEC on the deliberate release of genetically modified organisms into the environment. This directive is the responsibility of my colleague the Minister for the Environment and Local Government and it is enforced on his behalf by the Environmental Protection Agency. I understand that the GMO and novel foods sub-committee is in the process of preparing a report on GMOs and novel foods. No decision has yet been made as to its publication.

John Gormley

Question:

220 Mr. Gormley asked the Minister for Health and Children the novel foods and novel food ingredients classified as substantially equivalent to their non-novel counterparts in the European Union and which need not have official approval and authorisation before entering the market; and if he will make a statement on the matter. [5772/99]

John Gormley

Question:

242 Mr. Gormley asked the Minister for Health and Children the novel foods which come under the designation substantially equivalent; if this will exclude many novel foods from being properly labelled under the EC Regulation No. 258/97; and if he will make a statement on the matter. [6044/99]

I propose to take Questions Nos. 220 and 242 together.

Regulation (EC) No. 259/97 concerning novel foods and novel food ingredients came into force in all member states on 15 May 1997 and introduced a statutory pre-market approval system for novel foods, including genetically modified foods, throughout the European Union. The regulation provides that foods which are substantially equivalent to others do not have to undergo the same safety assessment that is required for all other novel foods. A novel food is substantially equivalent to an existing food if, on the basis of scientific evidence or an opinion delivered by one of the competent bodies for the purposes of this regulation, it is deemed to be identical as regards composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein. The labelling provisions of the regulations still apply to the food.

The World Health Organisation, WHO, and Organisation for Economic Co-Operation and Development, OECD, introduced the concept of substantial equivalance with particular reference to foods produced by modern biotechnology. This concept embodies the idea that existing organisms used as foods or food sources can serve as a basis for comparison when assessing the safety and nutritional value of a food or food ingredient that has been modified or is new. If a food or food ingredient is found to be substantially equivalent to an existing food or food ingredient, it can be treated in the same manner with respect to safety and nutritional value, keeping in mind that establishment of substantial equivalence is not a safety or nutritional assessment in itself, but an approach to compare a potential new food with its conventional counterpart.
If a company wants to launch a product on the EU market, it can deem the product to be substantially equivalent providing it falls into one of the following categories: foods and food ingredients produced from, but not containing GMOs; foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae; and foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use.
A company wishing to launch the product can claim substantial equivalance and then place the product on the market. In this instance, the company must inform the Commission that they are placing the product on the market. Alternatively, the company can approach a competent authority, claim that a product is substantially equivalent to another one and request verification of this claim. All other member states are informed by the Commission that such a product is being placed on the market and are given an opportunity to raise an objection about its substantially equivalent status. The following products have been notified to the Commission as substantially equivalent:

Applicant

Product Description

Date of Notification

AgrEvo UK Ltd.

Processed oil from genetically modified canola seed, transformation event TOPAS 19/2 and all conventional crossed

09.06.97

Plant Genetic Systems N.V.

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

10.06.97

Plant Genetic Systems N.V.

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

10.06.97

Monsanto Services International S.A.

Refined oil from glyphosate tolerant oilseed rape line GT73

10.11.97

Monsanto Services International S.A.

Food and food ingredients produced form maize flour, maize gluten, maize semolina, maize starch, maize glucose and maize oil derived from the progeny of maize line MON810

10.12.97

AgrEvo France S.A.

(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

12.01.98

Novartis Seeds AG

Food and food ingredient products derived from the original transformant Bt11 crossed with the Northup King Company inbred line #2044 (maize), as well as from any inbred and hybrid lines derived from it and containing the introduced genes

30.01.98

Pioneer Overseas Corporation

Novel foods and novel food ingredients produced from genetically modified maize line MON809

14.10.98

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