The Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002

A description of the methods used or a reference to standardised or internationally recognised methods used to compile the information required by this Schedule, and the name of the body or bodies responsible for carrying out the studies.

SCHEDULE 3 — INFORMATION TO BE INCLUDED IN AN APPLICATION FOR CONSENT TO MARKET GENETICALLY MODIFIED ORGANISMS

Part I — GENERAL INFORMATION

1

The proposed commercial name of the product and names of the genetically modified organisms in the product, the unique identifier assigned in accordance with Regulation 65/2004, and any other, name or code used by the applicant to identify the genetically modified organism.

2

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

3

The name and address of the supplier or suppliers of control samples.

4

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

5

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

6

A description of the intended categories of users of the product, such as industry, agriculture or consumer use by the public.

7

• (1) Information on—

• (a) methods for the detection, identification and, where appropriate, quantification of the transformation event,

• (b) samples of the genetically modified organisms and their control samples,

• (c) the place where the reference material can be accessed.

• (2) Information under sub-paragraph (1) that cannot be placed on the register for confidentiality reasons, must be identified.

8

The 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 ... who is responsible for the placing on the market, and how to access the information in the publicly accessible part of the register.

Part II — 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.

10

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

11

Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the National Assembly for Wales, which are consistent with Part C of Annex VII of the Deliberate Release Directive.

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.

13

The proposed packaging.

14

The estimated product in and/or imports to Wales.

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.

SCHEDULE 4 — INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT

1

An identification of the characteristics of the recipient organism which are relevant to the assessment of the relevant genetically modified organisms.

2

A description of the way in which the characteristics of the organisms have been affected by genetic modification.

3

An identification of any known risks of change to the environment resulting from the release into the environment of the recipient non-modified organism.

4

An assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and the environment.

5

An identification of any new risks to human health and the environment that may arise from the release of the relevant genetically modified organisms as compared to the release of the corresponding non-modified organism, based on the environmental risk assessment.

6

A conclusion which addresses the proposed use of the product, risk management and the proposed monitoring plan, and states whether the relevant genetically modified organisms should be marketed and under which conditions, or should not be marketed, including reasons for that conclusion...

SCHEDULE 5 — REVOCATIONS

Regulations revoked	References	Extent
The Genetically Modified Organisms (Deliberate Release) Regulations 1992	S.I. 1992/3280 as amended by the Genetically Modified Organisms (Deliberate Release) Regulations 1993 (S.I. 1993/152), the Genetically Modified Organisms (Deliberate Release) Regulations 1995 (S.I. 1995/304), the Genetically Modified Organisms (Deliberate Release and Risk Assessment-Amendment) Regulations 1997 (S.I. 1997/1900), and the Genetically Modified Organisms (Contained Use) Regulations 2000 (S.I. 2000/2831).	The whole Regulations
The Genetically Modified Organisms (Deliberate Release) Regulations 1993	S.I. 1993/152	The whole Regulations
The Genetically Modified Organisms (Deliberate Release) Regulations 1995	S.I. 1995/304	The whole Regulations
The Genetically Modified Organisms (Deliberate Release and Risk Assessment-Amendment) Regulations 1997	S.I. 1997/1900	Regulation 2
The Genetically Modified Organisms (Contained Use) Regulations 2000	S.I. 2000/2831	Regulation 31(2)

Signed

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998

D. Elis-Thomas — The Presiding Officer of the National Assembly — 2002-12-18

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: O.S. 2001/3495.

[^f00002]: 1972 p.68.

[^f00003]: 1990 p. 43. Trosglwyddwyd swyddogaethau'r Ysgrifennydd Gwladol o dan y darpariaethau hyn (ac eithrio adran 156) i Gynulliad Cenedlaethol Cymru o dan Erthygl 2 o ac Atodlen 1 i Orchymyn Cynulliad Cenedlaethol Cymru (Trosglwyddo Swyddogaethau) 1999 (O.S. 1999/672). Trosglwyddwyd swyddogaethau'r Gweinidog Amaethyddiaeth, Pysgodfeydd a Bwyd o dan y darpariaethau hyn i Gynulliad Cenedlaethol Cymru o dan Erthygl 2 o Orchymyn Cynulliad Cenedlaethol Cymru (Trosglwyddo Swyddogaethau) 2000 (O.S. 2000/253) ac Atodlen 1 iddo.

[^f00004]: OJ Rhif L117, 8.5.90, t.15.

[^f00005]: OJ Rhif L103, 22.4.94, t.20.

[^f00006]: OJ Rhif L169, 27.6.97, t.72.

[^f00007]: 2000 p.7.

[^f00011]: OJ Rhif L292, 12.11.1994, t.31.

[^f00012]: O.S. 1992/3280. Trosglwyddwyd swyddogaethau'r Ysgrifennydd Gwladol o dan y rheoliadau hyn i Gynulliad Cenedlaethol Cymru o dan Erthygl 3 ac Atodlen 1 i Orchymyn Cynulliad Cenedlaethol Cymru (Trosglwyddo Swyddogaethau) 2000 (O.S. 2000/253).

[^f00013]: Diwygiwyd adran 106(4) gan reoliad 3(3) ac mewnosodwyd adran 106(4A) i 106(4D) gan reoliad 3(4) o Reoliadau Organeddau a Addaswyd yn Enetig (Eu Gollwng yn Fwriadol) 2002, a rhoddir effaith iddynt yng Nghymru yn ddarostyngedig i addasiadau pellach gan reoliad 4 o'r Rheoliadau hyn.

[^f00016]: OJ Rhif L214, 24.8.1993, t.1.

[^f00017]: OJ Rhif L88, 24.3.1998, t.7.

[^f00019]: Gweler adran 10 o Ddeddf Iechyd a Diogelwch yn y Gwaith 1974 (p.37).

[^f00020]: O.J. Rhif L193, 20.7.2002, t1.

[^f00021]: O.J. Rhif L193, 20.7.2002, t33.

[^f00022]: Cyfarwyddeb y Cyngor 1999/105/EC ar farchnata deunydd atgenhedlu fforest OJ Rhif L11 15.1.2000 t. 17.

[^f00023]: Gweler adran 1 o Ddeddf Safonau Bwyd 1999 (p.28).

[^f00024]: 1998 p.38.

Editorial notes

[^c8716451]: S.I. 2001/3495.

[^c8716461]: 1972 c.68.

[^c8716511]: OJ No. L117, 8.5.90, p.15.

[^c8716521]: OJ No. L103, 22.4.94, p.20.

[^c8716531]: OJ No. L169, 27.6.97, p.72.

[^c8716541]: 2000 c.7.

[^c8716551]: OJ No. L292, 12.11.1994, p.31.

[^c8716561]: S.I. 1992/3280. The functions of the Secretary of State under these regulations were transferred to the National Assembly for Wales under Article 3 and Schedule 1 to the National Assembly for Wales (Transfer of Functions) Order 2000 (S.I. 2000/253).

[^c8716571]: Section 106(4) is amended by regulation 3(3) and section 106(4A) to 106(4D) is inserted by regulation 3(4) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002, and are given effect in Wales subject to further modification by regulation 4 of these Regulations.

[^c8716631]: See section 10 of the Health and Safety at Work etc. Act 1974 (c.37).

[^c8716671]: See section 1of the Food Standards Act 1999 (c.28).

[^c8716681]: 1998 c.38.

[^key-b01e48b83765b1d24548db513249de04]: Words in reg. 2 substituted (15.7.2005) by The Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005 (S.I. 2005/1913), regs. 1, 2(2)(a)

[^key-31f6b4bc38b71c3864dcf53e248a5f82]: Words in reg. 2 inserted (15.7.2005) by The Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005 (S.I. 2005/1913), regs. 1, 2(2)(b)

[^key-f213d9fe6c4e1107ab3dd098432ec002]: Words in reg. 16(a) inserted (15.7.2005) by The Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005 (S.I. 2005/1913), regs. 1, 2(3)(a)

[^key-526f2718a6c07232ddfe2d09adcb9be1]: Reg. 22(2) substituted (15.7.2005) by The Genetically Modified Organisms (Deliberate Release) (Wales) (Amendment) Regulations 2005 (S.I. 2005/1913), regs. 1, 2(5)

[^key-3f6787174a089c737aeb41879889e7d6]: Words in reg. 13(4)(e) substituted (1.4.2013) by The Natural Resources Body for Wales (Functions) Order 2013 (S.I. 2013/755), art. 1(2), Sch. 5 para. 16(2) (with Sch. 7)

[^key-687c765c9ac4030179ecd6f75067d4bd]: Reg. 13(4)(f) omitted (1.4.2013) by virtue of The Natural Resources Body for Wales (Functions) Order 2013 (S.I. 2013/755), art. 1(2), Sch. 5 para. 16(3) (with Sch. 7)

[^key-18d34b40e3abd9dc4120f1bd23129b1c]: Reg. 13(4)(c) substituted (17.12.2018) by The Environment, Planning and Rural Affairs (Miscellaneous Amendments) (Wales) Regulations 2018 (S.I. 2018/1216), regs. 1(3), 4(3)

[^key-eb2b64ff91f5cad978c08978a25a44cc]: Reg. 16(f) omitted (20.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/379), regs. 1(2), 2(2)

[^key-c76416a1e82eb3f2df1d60a0b89ced71]: Reg. 18 omitted (20.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/379), regs. 1(2), 2(3)

[^key-c66a564ff27295f9287cfc4324f1153b]: Reg. 18A omitted (20.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/379), regs. 1(2), 2(3)

[^key-376fb96a94d79ab28fa1dfaf723a9476]: Words in Sch. 3 para. 1 substituted (20.3.2019) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2019 (S.I. 2019/379), regs. 1(2), 2(4)

[^key-103aa08629f769a8ec2deab40d848fdb]: Words in reg. 2(1) substituted (28.3.2019) by The Rural Affairs, Environment, Fisheries and Food (Miscellaneous Amendments and Revocations) (Wales) Regulations 2019 (S.I. 2019/463), regs. 1(3), 17

[^key-85bae5856cc672dbf3cf6bb398cada0d]: Words in Sch. 1 heading substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(2)

[^key-52006082d07bd74e3cd978d12b1c2c8d]: Sch. 1 shoulder note substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(3)

[^key-2aaa1a5a918ecf6f3fe00812bc53f803]: Sch. 1 para. 15 substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(6)

[^key-2f1ab0160c7a9713b8c05e48fc076677]: Sch. 1 paras. 15A, 15B inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(7)

[^key-82ea0f3d489ceb9cea229e4fb544f2b1]: Sch. 1 Pt. 4A para. 18 substituted for Sch. 1 paras. 18-23 (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(9)

[^key-42ae928acb0a81e671556875ae910bca]: Words in Sch. 1 Pt. V omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(10)

[^key-4858a872429a05a24b86c049779b809f]: Words in Sch. 1 Pt. VI omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(11)

[^key-a47e970be234efc6acff25b1685ac486]: Words in Sch. 1 Pt. VII omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(12)

[^key-1600db295c56649ae5fc2cd92d99da6c]: Sch. 1 para. 35 substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(13)

[^key-dbfcf3594f8ab7676b640b74c1ddd759]: Sch. 1A inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 7

[^key-3fd3a4c6f229fe017f09c48d0a4b25e8]: Sch. 3 para. 7 substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 8

[^key-a7c09589e6ee7dfd220c24acd992b736]: Words in reg. 2 substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 3

[^key-18a93a4899ee4929e2f0a6aa94797eb5]: Reg. 12(1A) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(c)

[^key-2dc17e2689c26aee517dab3f11ebdcd2]: Reg. 12(1)(e) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(b)

[^key-c58240c82d8194129b7686d6040a3015]: Words in reg. 12(1)(a) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(a)(i)

[^key-ddbe22dfedd5129079c0902a14d57043]: Words in reg. 12(1)(a) omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 4(a)(ii)

[^key-0264f47b870525fad981ff1608282964]: Reg. 17(2A) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 5(c)

[^key-ebaeacbf170ae4536315a9965eb1a5a8]: Reg. 17(2)(k) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 5(b)

[^key-8f7151a740c3cfe26023ae4811364565]: Words in reg. 17(2)(a) inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 5(a)(i)

[^key-9f7f14fb655026376d7f7c6b3ea7aab5]: Words in reg. 17(2)(a) omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 5(a)(iii)

[^key-ceb6dfba6c3e4d381f9a20cad90d3dab]: Words in reg. 17(2)(a)(i) substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 5(a)(ii)

[^key-53b967d1f0802d19cd35d79d5a668b06]: Words in Sch. 1 para. 7 inserted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(4)

[^key-4e5b44142a45514df56651f0fa8d2c5e]: Words in Sch. 1 para. 8 substituted (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(5)

[^key-ae8330c71794d0527fadb114b075b218]: Sch. 1 para. 16 omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(8)

[^key-f0c7a8ddd0d40d82269166d7c74e9d6e]: Sch. 1 para. 17 omitted (30.10.2019) by virtue of The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(8)

[^M_F_8e468680-9ed1-4e96-a030-4ac2267f25f9]: Words in Sch. 1A para. 15(c) substituted by S.I. 2019/1316, reg. 7 (as amended) (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) (Amendment) Regulations 2019 (S.I. 2019/1407), regs. 1(2), 4(b)

[^key-54b8db032d8506b25d230a0a1a5cad64]: Words in reg. 17(2)(b) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(6)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

[^key-c3ae642da2a0d004e31f75649102e6b5]: Words in reg. 17(2)(b) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(6)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b4125a505968319421801db9728e724b]: Words in reg. 17(2)(g) inserted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-a180116960f913f5419030292ae86de5]: Words in reg. 17(2)(j) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(6)(c); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b780621ba8978cfcf05707d8b1814a0c]: Words in reg. 2(1) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-25a9674410c1ceb4f1fd5cb5c4230d06]: Words in reg. 2(1) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-427a5c4cfd94c58e152bbb37d116400b]: Words in reg. 2(1) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7fd6a00a44f7b39d6c7f6d93462f00d8]: Words in reg. 2(1) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(2)(d); 2020 c. 1, Sch. 5 para. 1(1)

[^key-c18f7a28e7021ad01e3321dfe3a1ec31]: Words in reg. 2(1) inserted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(2)(e); 2020 c. 1, Sch. 5 para. 1(1)

[^key-800443503136abcf208d40f447e603f6]: Reg. 16(g) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(e); 2020 c. 1, Sch. 5 para. 1(1)

[^key-76ad59eded45f3e3a2f94253fa3a889f]: Reg. 16(e) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(d); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4bef05d8f91b2d4208bf63c8b9ddf043]: Reg. 16(b) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-ef0bcf795f94111b820ae9535b6ef3be]: Reg. 16(c) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-5d7537fa3a7d91e5df501f8f2be20568]: Word in reg. 16(d) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(5)(c); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9c70391de4227fc8ed47d0a92a6c1d2b]: Words in reg. 10 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(3); 2020 c. 1, Sch. 5 para. 1(1)

[^key-ba13d98175e17cae707f037a101ede95]: Words in reg. 12(1)(d) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b40095af69b460a4c294190e6076c9e6]: Words in reg. 12(1)(d) inserted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-b2b69a82dc385b6b3605cc2ac1933a25]: Reg. 21(c) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(7)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-01b3b41cc44556415cef9ead77ea6866]: Words in reg. 21(f) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(7)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-6808c8f6450c275422cf864bab9046eb]: Words in reg. 22(3) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(8)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-191cba3d607d3c9eff4bc57d3b28044b]: Reg. 22(6) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(8)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-23d4dbb66b1a477b4c77a95c1061cfba]: Reg. 26(1)(d) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-679e34a79623810c06e9062fbd80873a]: Reg. 26(2) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(11); 2020 c. 1, Sch. 5 para. 1(1)

[^key-75eb1cc43c9e56a469d16861b401c5bd]: Reg. 27(1) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(12)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-a25792032d5da1106ec329c2ca9f0e54]: Reg. 27(2) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(12)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-c7b93198252f22792dec106950bb7e62]: Reg. 24 substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(9); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7be5c158882f93f5dfacc5a07ab9eb00]: Reg. 25 substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(10); 2020 c. 1, Sch. 5 para. 1(1)

[^key-14782481cfe1910dda588d906496bb02]: Words in reg. 29(f) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(13); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f1c5a7c7ac9a74d8de90d739683438b7]: Reg. 32 substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(14); 2020 c. 1, Sch. 5 para. 1(1)

[^key-d47607b9fc699d08310801c7f5a4dd91]: Reg. 33(3)-(5) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(15); 2020 c. 1, Sch. 5 para. 1(1)

[^key-85cda32239bbed6425c9580a227e86b6]: Reg. 35(1)-(9) substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-028da54606372cee21e9a7c9d43b163b]: Reg. 36 substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(17); 2020 c. 1, Sch. 5 para. 1(1)

[^key-9f174eb7f04a24df2a6bfe146453f75a]: Words in Sch. 3 para. 2 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(18)(a); 2020 c. 1, Sch. 5 para. 1(1)

[^key-76ca917185ab1746a23570219d4fee1e]: Words in Sch. 3 para. 5 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(18)(b); 2020 c. 1, Sch. 5 para. 1(1)

[^key-49b22b0351fd9d736913b787f316dbc0]: Words in Sch. 3 para. 8 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(18)(c); 2020 c. 1, Sch. 5 para. 1(1)

[^key-02c09a5c0b244f89914335f02f1368a5]: Word in Sch. 3 para. 14 substituted (31.12.2020) by The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(18)(d); 2020 c. 1, Sch. 5 para. 1(1)

[^key-17a7ac180283a233d250814d8746ba93]: Words in Sch. 4 para. 6 omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Deliberate Release and Transboundary Movement) (Miscellaneous Amendments) (Wales) (EU Exit) (No. 2) Regulations 2019 (S.I. 2019/1492), regs. 1(3), 2(19); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_afaa21ae-9a50-4e05-9c2b-8f49a872391f]: Sch. 1 Pt. 4A para. 18 substituted for Sch. 1 paras. 18-23 (30.10.2019) by The Genetically Modified Organisms (Deliberate Release) (Amendment) (Wales) Regulations 2019 (S.I. 2019/1316), regs. 1(2), 6(9)

Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation

18A

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Applications for renewal of consent to market

15A

The genetic stability of the insert and phenotypic stability of the genetically modified plant.

15B

Conclusions on the molecular characterisation of the genetically modified plant.

PART 4A — Information on specific areas of risk

SCHEDULE 1A — Information to be included in applications for consent to market genetically modified higher plants

PART 1 — General information

1

The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release.

2

The designation and specification of the genetically modified plant, and the scope of the application, in particular whether the application is in respect of cultivation, for some other use (which must be specified), or both.

PART 2 — Information relating to the parental or recipient plant

3

The full name of the plant—

• (a) family name,

• (b) genus,

• (c) species,

• (d) subspecies,

• (e) cultivar or breeding line,

• (f) common name.

4

Information concerning—

• (a) the reproduction of the plant—

• (i) the mode or modes of reproduction,

• (ii) any specific factors affecting reproduction,

• (iii) generation time, and

• (b) the sexual compatibility of the plant with other cultivated or wild plant species, including the distribution in Europe of the compatible species.

5

Information concerning the survivability of the plant—

• (a) its ability to form structures for survival or dormancy,

• (b) any specific factors affecting survivability.

6

Information concerning the dissemination of the plant—

• (a) the means and extent (such as an estimation of how viable pollen or seeds decline with distance where applicable) of dissemination, and

• (b) any specific factors affecting dissemination.

7

The geographical distribution of the plant in Europe.

8

Where the application relates to a plant species which is not normally grown in Europe, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

9

Any other potential interactions, relevant to the genetically modified organism, of the plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

PART 3 — Information Relating to the Genetic Modification

10

A description of the methods used for the genetic modification.

11

The nature and source of the vector used.

12

The size, intended function and name of the donor organism or organisms of each constituent fragment of the region intended for insertion.

PART 4 — Information relating to the genetically modified plant

13

A description of the trait or traits and characteristics of the genetically modified plant which have been introduced or modified.

14

• (1) The following information on the sequences inserted or deleted—

• (a) the size and structure of the insert and methods used for its characterisation, including information on any parts of the vector introduced into the genetically modified plant or any carrier or foreign DNA remaining in the genetically modified plant,

• (b) the size and function of the deleted region or regions, where appropriate,

• (c) the copy number of the insert,

• (d) the subcellular location of any insert in the plant cells (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form) and methods for its determination,

• (e) the organisation and sequence of the genetic material at each insertion site in a standardised electronic format,

• (f) the sequence of genomic DNA flanking each insertion site in a standardised electronic format,

• (g) bioinformatic analysis to identify interruptions of known genes,

• (h) information on Open Reading Frames (“ORFs”) within the insert and ORFs created at the junction of the insert and genomic DNA,

• (i) bioinformatic analysis to identify similarities between any ORFs generated by the genetic modification and known genes that may have adverse effects,

• (j) the amino acid sequence and if necessary, other structures of proteins produced as a results of the genetic modification,

• (k) bioinformatic analysis to identify sequence homologies, and if necessary, structural similarities, between proteins produced as a result of the genetic modification and known proteins and peptides with potential adverse effects,

• (l) in the case of genetic modifications other than insertion or deletion, information on the function of the genetic material targeted by the genetic modification before and after modification, as well as direct changes in the expression of genes as result of the modification.

• (2) In this paragraph, an ORF is a nucleotide sequence that contains a string of codons uninterrupted by the presence of a stop codon in the same reading frame.

15

The following information on the expression of the insert—

• (a) information on the developmental expression of the inserted or modified DNA during the lifecycle of the plant and methods used for its characterisation,

• (b) the parts of the plant where the insert is expressed, such as roots, stem or pollen,

• (c) the potential unintended expression of a new ORF (which has the meaning given in paragraph 14(2)), which has resulted from the insertion or deletion of genetic material into a known gene (as identified under paragraph 14(1)(g)) and which raises a safety concern,

• (d) protein expression data from genetically modified plants grown under field conditions.

16

The genetic stability of the insert and phenotypic stability of the genetically modified plant.

17

Conclusions on the molecular characterisation of the genetically modified plant.

18

The following information on the comparative analysis of agronomic and phenotypic characteristics and of composition—

• (a) choice of a conventional counterpart and any additional comparators used in comparative analyses,

• (b) choice of field site location for producing plant material for comparative analyses,

• (c) experimental design including statistical analysis,

• (d) selection of plant material for analysis, where relevant,

• (e) comparative analysis of agronomic and phenotypic characteristics,

• (f) comparative analysis of composition, if relevant,

• (g) conclusions of comparative analysis.

PART 5 — Information on specific areas of risk

19

For each of the areas of risk listed in section D.2 of Annex 2 to the Deliberate Release Directive the applicant must describe each pathway through which harm could occur in respect of the release of a genetically modified plant, taking hazard and exposure into account.

20

The applicant must provide—

• (a) the information described in paragraphs 21 to 27, and

• (b) the overall risk evaluation and conclusions described in paragraph 28,

except where the applicant considers it is not relevant in view of the intended use of the genetically modified plant.

21

Information relating to the persistence and invasiveness including plant to plant gene transfer including—

• (a) an assessment of the potential for the genetically modified plant to become more persistent or invasive and the adverse environmental effects arising,

• (b) an assessment of the potential for the genetically modified plant to transmit transgenes to sexually compatible relatives and the adverse environmental effects arising,

• (c) conclusions on the adverse environmental effect of persistence and invasiveness of the genetically modified plant including the adverse environmental effect of plant to plant gene transfer.

22

Information relating to plant to micro-organism gene transfer including—

• (a) an assessment of the potential for transfer of newly inserted DNA from the genetically modified plant to micro-organisms and the adverse effects arising,

• (b) conclusions on the adverse effect of the transfer of newly inserted DNA from the genetically modified plant to micro-organisms on human and animal health and the environment.

23

Information relating to the interactions of the genetically modified plant, if relevant, with target organisms including—

• (a) an assessment of the potential for changes in the direct and indirect interactions between the genetically modified plant and target organisms and the adverse environmental effects arising,

• (b) an assessment of the potential for evolution of resistance of the target organism to the expressed protein based on the history of evolution of resistance to conventional pesticides or transgenic plants expressing similar traits, and any adverse environmental effects arising,

• (c) conclusions on adverse environmental effects of interactions of the genetically modified plant with target organisms.

24

• (1) Information on the interactions of the genetically modified plant with non-target organisms including—

• (a) an assessment of the potential for direct and indirect interactions of the genetically modified plant with non-target organisms, including protected species, and the adverse effect arising,

• (b) conclusions on adverse environmental effects of interactions of the genetically modified plant with non-target organisms.

• (2) The assessment described in sub-paragraph (1) must take into account the potential adverse effect on relevant ecosystem services and on the species providing those services.

25

Information on the impacts of the specific cultivation, management and harvesting techniques including—

• (a) in respect of genetically modified plants for cultivation, an assessment of the changes in the specific cultivation, management and harvesting techniques used for the genetically modified plant and the adverse environmental effects arising,

• (b) conclusions on adverse environmental effects of the specific cultivation, management and harvesting techniques.

26

Information on biogeochemical processes including—

• (a) an assessment of the potential changes in the biogeochemical processes within the area in which the genetically modified plant is to be grown and in the wider environment, and the adverse effects arising,

• (b) conclusions on adverse effects on biogeochemical processes.

27

Information on the effects on human and animal health including—

• (a) an assessment of potential direct and indirect interactions between the genetically modified plant and persons working with or coming into contact with the genetically modified plant, including through pollen or dust from a processed genetically modified plant, and assessment of the adverse effects of those interactions on human health,

• (b) for a genetically modified plant not destined for human consumption, but where the recipient or parental organisms may be considered for human consumption, assessment of the likelihood of and possible adverse effects on human health due to accidental intake,

• (c) an assessment of the potential adverse effects on animal health due to accidental consumption of the genetically modified plant or of material from that plant by animals,

• (d) conclusions on the effects on human and animal health.

28

• (1) The overall risk evaluation and conclusions must include a summary of each of the conclusions specified in paragraphs 21 to 27.

• (2) The summary referred to in sub-paragraph (1) must take into account the risk characterisation in accordance with steps 1 to 4 of the methodology described in Section C.3 of Annex 2 and the risk management strategies proposed in accordance with point 5 of Section C.3 of Annex 2 to the Deliberate Release Directive.

PART 6 — Information about the detection, identification and previous releases of the genetically modified plant

30

A description of detection and identification techniques for the genetically modified plant.

31

Information about previous releases of the genetically modified plant, if applicable.

Duties of the Welsh Ministers in relation to applications for consent to market genetically modified organisms

Decisions by the Welsh Ministers on applications for consent to market genetically modified organisms

Variation or revocation of a consent to market

Enwi, cychwyn a chymhwyso

Dehongli

Dynodi awdurdod cymwys

Diben Rhan VI o'r Ddeddf ac ystyr “organeddau a addaswyd yn enetig” ayb

Ystyr “damage to the environment” ayb

Technegau addasu genetig

Asesiad risg amgylcheddol

Cyfathrebu â cheisydd am ganiatâd

Y gofyniad am ganiatâd i ollwng

Gweithgareddau esempt

Ceisiadau am ganiatâd i ollwng — darpariaethau cyffredinol

Gwybodaeth i'w chynnwys mewn cais am ganiatâd i ollwng

Hysbysebu cais am ganiatâd i ollwng

Darpariaethau trosiannol ar gyfer gollwng

Y gofyniad am ganiatâd i farchnata

Gweithgareddau esempt

Cais am ganiatâd i farchnata

Darpariaeth drosiannol ar gyfer marchnata

Ceisiadau am adnewyddu caniatâd i farchnata

Dyletswydd y ceisydd ar ôl gwneud cais am ganiatâd i ollwng neu i farchnata

Dyletswyddau Cynulliad Cenedlaethol Cymru wrth gael ceisiadau am ganiatâd i ollwng

Penderfyniadau gan Gynulliad Cenedlaethol Cymru ar geisiadau am ganiatâd i ollwng

Amrywio neu ddiddymu caniatâd i ollwng organeddau a addaswyd yn enetig

Dyletswyddau Cynulliad Cenedlaethol Cymru mewn perthynas â cheisiadau am ganiatâd i farchnata organeddau a addaswyd yn enetig

Penderfyniadau gan Gynulliad Cenedlaethol Cymru ar geisiadau am ganiatâd i farchnata organeddau a addaswyd yn enetig

Dyletswyddau Cynulliad Cenedlaethol Cymru wrth gael ceisiadau am adnewyddu caniatâd i farchnata organeddau a addaswyd yn enetig

Penderfyniadau gan Gynulliad Cenedlaethol Cymru ar geisiadau i adnewyddu caniatâd i farchnata organeddau a addaswyd yn enetig

Organeddau a addaswyd yn enetig sy'n cynnwys marcwyr ymwrthedd gwrthfiotig

Darpariaethau cyffredinol caniatadau i farchnata organeddau a addaswyd yn enetig

Amodau cyffredinol mewn caniatadau i ollwng neu farchnata organeddau a addaswyd yn enetig

Prawf o gydymffurfio ag amodau'r caniatâd

Gwybodaeth newydd am y risgiau o beri niwed i'r amgylchedd

Amddiffyniad

Cyfrinachedd

Gwybodaeth sydd i'w chynnwys ar y gofrestr

Cadw'r gofrestr

Cyhoeddi sylwadau

Yr egwyddor ragofalus

Dirymiadau

Cymhwyso Rhan VI o'r Ddeddf i'r môr tiriogaethol

Cymhwyso Rhan VI o'r Ddeddf i Gymru

...

...

...

Nodweddion yr organeddau rhoi, yr organeddau rhieniol a'r organeddau derbyn

Nodweddion y fector

Nodweddion yr organeddau a addaswyd yn enetig

Nodweddion organeddau a addaswyd yn enetig

Y gollyngiad

Yr amgylchedd (ar y safle ac yn yr amgylchedd ehangach)

Nodweddion sy'n effeithio ar oroesiad, lluosiad a lledaeniad

Rhyngweithiadau â'r amgylchedd

Technegau monitro

Rheoli'r gollyngiad

Trin gwastraff

Cynlluniau ymateb mewn argyfwng

Mesurau trosiannol ar gyfer presenoldeb damweiniol neu dechnegol anochel deunydd a addaswyd yn enetig sydd wedi elwa o werthusiad risg ffafriol

Ceisiadau am adnewyddu caniatâd i farchnata