Statutory Instrument 1997 No. 1900

The Genetically Modified Organisms (Deliberate Release and Risk Assessment-Amendment) Regulations 1997

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© Crown Copyright 1997

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" (e) the marketing of a novel food or novel food ingredient within the scope of Regulation (EC) No 258/97 of the European Parliament and of the Council[5]".

    (3) For Schedule 2 to the Genetically Modified Organisms (Deliberate Release) Regulations 1992[6] there is substituted the Schedule 2 set out in the Schedule to these Regulations.

Amendment of Regulations - Risk Assessment
     3. In paragraph (2) of regulation 3 of the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996[7], there is added at the end the following sub-paragraph-

" (e) are or are contained in a novel food or novel food ingredient which is authorised for marketing in accordance with the provisions of Regulation (EC) No 258/97 of the European Parliament and of the Council[8]."

Signed by authority of the Secretary of State for the Environment


Michael Meacher
Minister of State, Department of the Environment, Transport and the Regions

28th July 1997


Jeff Rooker
Minister of State, Ministry of Agriculture, Fisheries and Food

29th July 1997



Signed by authority of the Secretary of State for the Welsh Office


Win Griffiths
Parliamentary Under-Secretary of State, Welsh Office

30th July 1997


Sewel
Parliamentary Under-Secretary of State, Scottish Office

30th July 1997

" SCHEDULE 2Regulation 11(1)(c)


INFORMATION TO BE CONTAINED IN AN APPLICATION FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS



PART I
GENERAL INFORMATION
     1. The name of the product and the name of the genetically modified organisms in the product.

     2. The name and address in the Community of the manufacturer or distributor of the product.

     3. The specificity of the product and the exact conditions of use including, where appropriate, the type of environment and/or the geographical areas within the Community for which the product is suited.

     4. The type of expected use of the product and the description of the persons who are expected to use the product.

    4a. Information relating to the introduced genetic modification which could be of relevance to the establishment of a possible register of modifications introduced into organisms [species]. This may include nucleotide sequences or any other type of information which is relevant for inclusion in such a register.

    4b. Information regarding proposed labelling which must include, in a label or an accompanying document, an indication that the product contains, or consists of, genetically modified organisms. In the case of products to be placed on the market in mixtures with non-genetically modified organisms, it is sufficient to indicate the possibility that genetically modified organisms may be present.



PART II
ADDITIONAL RELEVANT INFORMATION
     5. The measures to be taken in the event of the escape of the organisms in the product or misuse of the product.

     6. Specific instructions or recommendations for storage and handling of the product.

     7. The estimated level and amount of production within the Community and the estimated level and amount of imports of the product into the Community.

     8. Information regarding the proposed packaging for the product and its appropriateness so as to avoid the escape of genetically modified organisms during storage or at a later stage.

     9. Information regarding proposed labelling including the proposals for stating, in full or summarised form, the information prescribed in paragraphs 1 to 3, 5 and 6 above."

[2] 1972 c. 68.back

[3] S.I. 1991/755.back

[4] 1992/3280; the relevant amending instrument is S.I. 1995/304.back

[5] OJ No. L 43, 14.2.97, p. 1. A Regulation of the European Parliament and of the Council concerning novel foods and novel food ingredients. The Regulation provides for specific environmental risk assessment of novel foods or novel food ingredients which contain or consist of genetically modified organisms.back

[6] 1992/3280; the relevant amending instrument is S.I. 1995/304.back

[7] S.I. 1996/1106.back

[8] OJ No. L 43, 14.2.97, p. 1.back