The Genetically Modified Organisms (Deliberate Release) Regulations 1995

• Citation: S.I. 1995/304
• Sections: 138

Section 1 Citation and commencement

(1) These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) Regulations 1995 and shall come into force on 8th March 1995.

Section 2 Interpretation

In these Regulations “the 1992 Regulations ” means the Genetically Modified Organisms (Deliberate Release) Regulations 1992 .

Section 3 Implementation of Commission Directive 94/15/ EC

(1) In regulation 2 of the 1992 Regulations (Interpretation), there shall be inserted after the definition of “heritable genetic material” the following definition—

“higher plant” means a plant belonging to the taxonomic group Gymnospermae or Angiospermae;

(2) For sub-paragraph (a) of paragraph (1) of regulation 6 of the 1992 Regulations (Information to be contained in an application for consent to release), there shall be substituted the following sub-paragraph—

(a) the information prescribed in—

(i) Schedule 1 to these Regulations, where the application is for consent to release any genetically modified higher plant; or

(ii) Schedule 1A to these Regulations, in any other case,

to the extent that such information is appropriate to the proposed release,

(3) In paragraph (2) of regulation 6 of the 1992 Regulations, after “Schedule 1” there shall be added “and Schedule 1A”.

(4) Paragraphs (3) and (4) of regulation 6 of the 1992 Regulations shall be deleted.

(5) For sub-paragraph (a) of paragraph (1) of regulation 11 of the 1992 Regulations (Information to be contained in an application for consent to market), there shall be substituted the following sub-paragraph—

(a) the information prescribed in—

(i) Schedule 1 to these Regulations, where the application is for consent to market any genetically modified higher plant; or

(ii) Schedule 1A to these Regulations, in any other case,

to the extent that such information is appropriate to the nature and scale of the release which may result from the marketing,

(6) In paragraph (2) of regulation 11 of the 1992 Regulations, after “Schedule 1” there shall be added “and Schedule 1A”.

(7) Paragraphs (3) and (4) of regulation 11 of the 1992 Regulations shall be deleted.

(8) For Schedule 1 to the 1992 Regulations there shall be substituted the Schedules set out in the Schedule to these Regulations.

Section 4 Amendment of the provisions relating to applications for consent to release

(1) In regulation 2 of the 1992 Regulations (interpretation) there shall be inserted—

(a) after the definition of “the Act” the following definition—

“application for a consent to release” shall include any notification made under the First Simplified Procedure (crop plants) Decision and cognate expressions shall be construed accordingly;

(b) before the definition of “the Deliberate Release Directive”, the following definition—

“controlled waters” in relation to England and Wales, has the meaning given by section 104 of the Water Resources Act 1991 and, in relation to Scotland, the meaning given by s. 30A of the Control of Pollution Act 1974 .

(c) after the definition of “the Deliberate Release Directive” the following definition—

“the First Simplified Procedure (crop plants) Decision” means Commission Decision 94/730/EC ;

(2) In paragraph (2) of regulation 5 of the 1992 Regulations (Consent to release organisms), after the words “the Secretary of State, and” there shall be inserted the words “, unless made under and in accordance with the provisions set out in the First Simplified Procedure (crop plants) Decision,”.

(3) In sub-paragraph (a) of paragraph (1) of regulation 6 of the 1992 Regulations after the words “appropriate to the proposed release” there shall be added the words “or application”.

(4) In paragraph (1) of regulation 8 of the 1992 Regulations (Advertisement of application for consent to release), for the words “Subject to paragraph (2)”, there shall be substituted the words “Subject to paragraphs (1A) and (2)”.

(5) After paragraph (1) of regulation 8 of the 1992 Regulations there shall be inserted the following new paragraph—

(1A) A notice published under paragraph (1) above need not contain the information referred to in sub-paragraphs (c) and (d) of that paragraph insofar as the First Simplified Procedure (crop plants) Decision does not require that information to be submitted with the application and that information is not submitted with the application.

(6) In paragraph (3) of regulation 8 of the 1992 Regulations, after the words “the information prescribed in paragraph in paragraph (1)(a) to (d)” there shall be inserted the words “,save insofar as paragraph (1A) permits such information to be excluded from the notice referred to in paragraph (1)”.

Section 5 Amendment of the requirements for advertising applications for consent to release

(1) In paragraph (1) of regulation 8 of the 1992 Regulations (Advertisement of application for consent to release) for the words “not less than fourteen days and not more than twenty-eight days after acknowledgement of receipt of that application is sent to him by the Secretary of State,”, there shall be substituted the words “not more than ten days after he sends that application to the Secretary of State,”.

(2) In paragraph (3) of regulation 8 of the 1992 Regulations—

(a) for the words “not less than fourteen days and not more than twenty-eight days after acknowledgement of receipt of that application is sent to him by the Secretary of State”, there shall be substituted the words “not more than ten days after he sends that application to the Secretary of State,”;

(b) in sub-paragraph (a), for the words “the site of the proposed release,” there shall be substituted the words “any site of a proposed release specified in the application for a consent to release,”;

(c) sub-paragraphs (b), (d), (e), and (g) shall be deleted; and

(d) at the beginning of sub-paragraph (f) there shall be added the words “if the proposed release may have an impact on any controlled waters,”.

Section 6 Amendment of the cases and circumstances in which a marketing consent is required

(1) In regulation 2 of the 1992 Regulations (Interpretation), there shall be inserted immediately after the definition of “the Commission” the following definition—

“the Contained Use Directive” means Council Directive 90/219/ EEC on the contained use of genetically modified micro-organisms ;

(2) In paragraph (1) of regulation 10 of the 1992 Regulations (Consent to market products)—

(a) between the words “cases and circumstances other than” and “the marketing of a product” there shall be inserted “(a)”;

(b) after the words “the Deliberate Release Directive” there shall be added the following—

; (b) the marketing of a product containing genetically modified micro-organisms within the meaning of Article 2 of the Contained Use Directive, the conditions of sale for which specify that it is to be used only in conditions of contained use in accordance with the Contained Use Directive; (c) the marketing of a medicinal product for human or veterinary use within the meaning of Council Regulation (EEC) No. 2309/93 ; (d) the marketing of an additive within the meaning of regulation 2(1) of the Feeding Stuffs Regulations 1991 incorporated in or for incorporation in any feeding stuff within the meaning of regulation 2(1) as aforesaid.

Section 7 Amendment of provisions relating to keeping of the register

(1) at the end of sub-paragraph (3)(c) of regulation 17 (Information to be included in register) there shall be added the words “to the extent that this information is contained in the application for consent,”

(2) at the end of sub-paragraph (3)(e) of regulation 17 (Information to be included in register) there shall be added the words “to the extent that this information is contained in the application for consent,”

(3) In paragraph (2) of regulation 18 of the 1992 Regulations (Keeping of the register) for the words “fourteen days” there shall be substituted the words “twelve days”.

Section 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.

Section 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.

Section 2

The title of the project.

Section 2

The title of the project.

Section 3

The full name of the plant:

(a) family name,

(b) genus,

(c) species,

(d) subspecies,

(e) cultivar/breeding line,

(f) common name.

Section 3 Characteristics of the donor, parental and recipient organisms

Scientific name and taxonomy.

Section 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.

Section 4 Characteristics of the donor, parental and recipient organisms

Usual strain, cultivar or other name.

Section 5

Information concerning the survivability of the plant:

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

(b) any specific factors affecting survivability.

Section 5 Characteristics of the donor, parental and recipient organisms

Phenotypic and genetic markers.

Section 6

Information concerning the dissemination of the plant:

(a) the means and extent of dissemination; and

(b) any specific factors affecting dissemination.

Section 6 Characteristics of the donor, parental and recipient organisms

The degree of relatedness between the donor and recipient or between parental organisms.

Section 7

The geographical distribution of the plant.

Section 7 Characteristics of the donor, parental and recipient organisms

The description of identification and detection techniques.

Section 8

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

Section 8 Characteristics of the donor, parental and recipient organisms

The sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques.

Section 9

The potentially significant interactions of the plant with organisms other than plants in the ecosystem where it is usually grown, including information on toxic effects on humans, animals and other organisms.

Section 9 Characteristics of the donor, parental and recipient organisms

The description of the geographical distribution and of the natural habitat of the organisms including information on natural predators, prey, parasites and competitors, symbionts and hosts.

Section 10

A description of the methods used for the genetic modification.

Section 10 Characteristics of the donor, parental and recipient organisms

The potential of the organisms for genetic transfer and exchange with other organisms.

Section 11

The nature and source of the vector used.

Section 11 Characteristics of the donor, parental and recipient organisms

Verification of the genetic stability of the organisms and factors affecting that stability.

Section 12

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

Section 12 Characteristics of the donor, parental and recipient organisms

The following pathological, ecological and physiological traits—

(a) the classification of hazard according to existing Community rules concerning the protection of human health and the environment;

(b) the generation time in natural ecosystems, and sexual and asexual reproductive cycle;

(c) survivability, including seasonability and the ability to form survival structures, including seeds, spores and sclerotia;

(d) pathogenicity, including infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organisms and possible activation of latent viruses (proviruses) and ability to colonize other organisms;

(e) antibiotic resistence, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy;

(f) involvment in environmental processes including primary production, nutrient turnover, decomposition of organic matter and respiration.

Section 13

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

Section 13 Characteristics of the donor, parental and recipient organisms

The sequence, frequency of mobilization and specificity of indigenous vectors and the presence in those vectors of genes which confer resistance to environmental stresses.

Section 14

The following information on the sequences actually 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 regions,

(c) the location of the insert in the plant cells (whether it is integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form) and the methods for its determination,

(d) the copy number of the insert.

Section 14 Characteristics of the donor, parental and recipient organisms

The history of genetic modification.

Section 15

The following information on the expression of the insert:

(a) information on the expression of the insert and methods used for its characterisation,

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

Section 15 Characteristics of the vector

The nature and source of the vector.

Section 16

Information on how the genetically modified plant differs from the parental or recipient plant in the following respects:

(a) mode or modes and/or the rate of reproduction,

(b) dissemination,

(c) survivability.

Section 16 Characteristics of the vector

The sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organisms and to make the introduced vector and insert function in those organisms.

Section 17

The genetic stability of the insert.

Section 17 Characteristics of the vector

The frequency of mobilisation, genetic transfer capabilities and/or methods of determination of the inserted vector.

Section 18

The potential for a transfer of genetic material from the genetically modified plants to other organisms.

Section 18 Characteristics of the vector

The degree to which the vector is limited to the DNA required to perform the intended function.

Section 19

Information on any toxic or harmful effects on human health and the environment arising from the genetic modification.

Section 19 Characteristics of the modified organisms

The methods used for the modification.

Section 20

The mechanism of interaction between the genetically modified plants and target organisms.

Section 20 Characteristics of the modified organisms

The methods used—

(a) to construct inserts and introduce them into the recipient organism;

(b) to delete a sequence.

Section 21

Any potentially significant interactions with non-target organisms.

Section 21 Characteristics of the modified organisms

The description of any insert and/or vector construction.

Section 22

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