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

Regulation 2(3)

SCHEDULE SCHEDULE 2 TO THE GENETICALLY MODIFIED ORGANISMS (DELIBERATE RELEASE) REGULATIONS 1992 AS SUBSTITUTED BY THESE REGULATIONS

Regulation 11(1)(c)

“SCHEDULE 2 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.”