Regulations 16(2), 16(5) and 28

SCHEDULE 4 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS

PART I S GENERAL INFORMATION

[F1 1.  The proposed commercial name of the product or products (which must be provided to the [F2 Scottish Ministers] after consent has been granted) and name or names of the genetically modified organism or organisms in the product or products, and a proposal for a unique identifier of the genetically modified organism developed in accordance with Commission Regulation (EC) No 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms.] S

Textual Amendments

F1 Sch. 4 para. 1 substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 19(a)

F2 Words in sch. 4 para. 1 substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(a); 2020 c. 1, Sch. 5 para. 1(1)

2.  The name and address F3 ... of the person who is responsible for the placing on the market, whether it be the manufacturer, importer or distributor. S

Textual Amendments

F3 Words in sch. 4 para. 2 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(b); 2020 c. 1, Sch. 5 para. 1(1)

3.  The name and address of the supplier of control samples. S

4.  A description of how the product and the genetically modified organism as or in the product are intended to be used, highlighting any differences in use or management of the genetically modified organism compared to similar non-genetically modified products. S

5.  A description of the geographical area and types of environment where the product is intended to be used F4 ..., including, where possible, an estimate of the scale of use in each area. S

Textual Amendments

F4 Words in sch. 4 para. 5 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(c); 2020 c. 1, Sch. 5 para. 1(1)

6.  A description of the intended categories of users of the product, such as industry, agriculture, skilled trades or consumer use by the public at large. S

[F5 7.   Methods for the detection, identification and, where appropriate, quantification of the transformation event, samples of the genetically modified organism or organisms and their control samples, and information as to the place where the reference material can be accessed (identifying any such information that cannot be placed, for confidentiality reasons, in the [F6 register]).] S

Textual Amendments

F5 Sch. 4 para. 7 substituted (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 19(b)

F6 Word in sch. 4 para. 7 substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(d); 2020 c. 1, Sch. 5 para. 1(1)

8.  Information regarding proposed labelling, which must include, in a label or an accompanying document, at least in summarised form, a commercial name of the product, a statement that “This product contains genetically modified organisms”, the name of the genetically modified organism and the name and address of the person F7 ... who is responsible for the placing on the market, and how to access the information in the publicly accessible part of the register. S

Textual Amendments

F7 Words in sch. 4 para. 8 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(e); 2020 c. 1, Sch. 5 para. 1(1)

PART II S ADDITIONAL RELEVANT INFORMATION

9.  The measures to be taken in the event of the escape of the organisms in the product or misuse of the product. S

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

11.  Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the Scottish Ministers, which are consistent with [F8 Part C of schedule 5A], so that the Scottish Ministers can be effectively informed of any adverse effect. S

Textual Amendments

F8 Words in sch. 4 para. 11 substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(f); 2020 c. 1, Sch. 5 para. 1(1)

12.  The proposed restrictions in the approved use of the genetically modified organism, such as where the product may be used and for what purposes. S

13.  The proposed packaging. S

14.  The estimated production in and/or imports to [F9 Scotland and other parts of the United Kingdom]. S

Textual Amendments

F9 Words in sch. 4 para. 14 substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(27)(g); 2020 c. 1, Sch. 5 para. 1(1)

15.  Any proposed additional labelling, which may include, at least in summarised form, the information referred to in paragraphs 4 and 5 of Part I of this Schedule, or paragraphs 9 to 12 of this Part. S