Regulation (2002:1086) On The Release Of Gmos Into The Environment

Original Language Title: Förordning (2002:1086) om utsättning av genetiskt modifierade organismer i miljön

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1 Cape. Introductory provisions



§ 1 the provisions of this Regulation shall apply to the management of

genetically modified organisms (GMOs), with the exception of the contained

use the Regulation (2000:271) on the contained

the use of genetically modified organisms.



paragraph 2 of this regulation,



Directive 2001/18/EC: European Parliament and Council directive

2001/18/EC of 12 March 2001 on the deliberate release into the environment of

genetically modified organisms and repealing

Council Directive 90/220/EEC, as last amended by Directive

2008/27/EC,



Regulation (EC) no 1946/2003 of the European Parliament and the Council

Regulation (EC) no 1946/2003 of 15 July 2003 on

transboundary movement of genetically modified

organisms,



the deliberate release into the environment: deliberate release as defined in

13 chapter. section 6 of the environmental code, which does not involve a placing on the

market, and



supervisory authority: an authority referred to in Chapter 2. 4, 13, 14, 15,

16, 17 or 18 § environmental protection Regulation (2011:13) has responsibility

for supervision in the case of the deliberate release, placing on the

market or cross-border movement.



In addition, the terms and expressions for the purposes of this regulation the same

meaning as in chapter 13. the environmental code. Regulation (2011:37).



section 3 for the purposes of this regulation,

regulators and operators, in accordance with

the precautionary principle, ensure that the appropriate measures are taken

necessary to avoid such adverse effects on

human health or the environment which may arise when genetic

modified organisms deliberate release or placing on the

the market.



Exemptions for certain activities



section 4 of the provisions on the deliberate release into the environment and placing on the

market in 13 chapter. the Environment Act shall not apply to



1. the genetically modified humans,



2. organisms that are produced or obtained by

mutagenesis, or



3. organisms that are produced or obtained by

cell fusion (including protoplast fusion) of plant cells in cases where

the plant can also be produced by traditional

breeding methods.



The derogations provided for in the first paragraph 2 and 3 shall not apply where

the production of recombinant-nucleic acid molecules

or genetically modified organisms made by other

manner than provided for in the first subparagraph 2 and 3.



section 5 of the provisions of §§ 6-9 and 2-Chapter 5. This regulation

does not apply to the carriage of genetically modified organisms on

Road, rail, inland waterway, sea or air.



Risk assessment and general conditions for

application review



section 6 of the 13 chapter. section 8 environmental code provides for

the deliberate release and placing on the market of genetically

modified organisms shall be preceded by an investigation that can

be used as a basis for the assessment of injury risks.



The risk assessment shall be carried out in accordance with Annex I to this

Regulation. Special attention will be paid to genetic

modified organisms with genes conferring resistance to

antibiotics used in medical or veterinary

treatment.



section 7 of The carrying on or intending to carry on an activity which

involves the deliberate release or the placing on the market

of genetically modified organisms shall implement the

investigation is needed for risk assessment.



section 8 By the approval procedure under this Regulation shall

the regulatory authority in each case make sure it is done

a careful assessment of the immediate or delayed

potential adverse effects on human health or the environment

which may occur directly or indirectly through gene transfer from

GMOs to other organisms.

The assessment shall also include such environmental impact which is

depending of the vulnerable nature of the organism and the host

environment.



8 AOF the environmental protection agency to provide guidance to

regulatory authorities and assist them in their assessments of

risks to the environment according to section 8 of the European Parliament and of the Council

Regulation (EC) No 1829/2003 of 22 september 2003 on

genetically modified food and feed.

Regulation (2010:1112).



section 9 in the case of genes for antibiotic resistance referred to

in section 6, second paragraph, and that can have negative effects on

human health or the environment, the following applies.

State examination and authorization decision taken pursuant to this regulation

shall



1. contribute to the gradual elimination of such genes and



2. ensure that such genes have been completely eliminated by the

31 december 2004 in genetically modified organisms are released

on the market and at the latest by 31 december 2008 in the genetically

modified organisms that are subject to the deliberate release into the environment.



Precautions



section 10 of the supervisory authority may, within its regulatory area Info

more detailed rules relating to such precautionary measures referred to

in Chapter 2. section 3 of the environmental code.



Before a regulator Announces regulations referred to in the first

paragraph, the gene technology Committee, the environmental protection agency and the

other regulatory authorities to submit their comments. If

the provisions relating to the carriage of genetically modified

organisms, is also the Swedish civil

preparedness will be given opportunity to comment Regulation (2008:1033).



Chapter 2. The deliberate release into the environment



Exemption from licensing



section 1 of the regulatory authority may, within its regulatory area Info

regulations that certain activities that constitute deliberate

the release should not be subject to authorisation under 13

Cape. section 12 of the Environment Act or the provisions of this chapter.



Such regulations may be notified only if the conditions

referred to in article 5 of Directive 2001/18/EC are fulfilled.



Application for authorization



section 2 of the application for authorisation for the deliberate release into the environment shall be made

of the supervisory authority responsible supervisory developments.

The Authority also examines issues of State.



section 3 of the application for authorization must contain technical information

and other information, to the extent set out in annex 2

to this regulation, a summary of this information

and such a risk assessment referred to in Chapter 1. section 6.

Conclusions of the risk assessment must meet the requirements of annex

1 section D to this regulation.



The supervisory authority may, within its regulatory area Info

regulations on how the summary shall be drawn up.



4 section instead of submitting information may an applicant reference

to data or results from previous applications. A

reference to secret information in someone else's past

application may be made only if the prior applicant admitted it.



§ 5 If the regulator does not decide otherwise an application

If the condition include several releases of the same GMOs

modified organisms (GMOs) or a combination of genetically

modified organisms, on a site or in multiple sites,

provided that the release (s) implemented for the same

purposes and for a fixed period of time.



section 6 supervisory authority may, in the particular case give

exemption from the requirements of paragraph 3 of the documentation. A waiver may

be granted only if the applicant shows that the exemption is consistent with the

an order issued pursuant to article 7 of Directive

2001/18/EC.



The supervisory authority may, within its regulatory area Info

the regulations required as a result of the EU decision.



If the applicant has requested an exemption, the regulatory authority

notify the European Commission of its decision in

exemption issue. Regulation (2010:1193).



Granting of permits



7 § When the regulatory authority has received an application, the

to the applicant send a confirmation of this and specify the

the date the application was received.



paragraph 8 of the supervisory authority shall ensure that the requirements

to the provisions of section 3 are met and whether the risk assessment can

is considered real.



The regulatory authority may order the applicant to submit the

additional information required for the granting of permits. A

such injunction shall be justified.



section 9, within 30 days after the application is received to

the regulator send a summary of the application

to the European Commission. The summary shall be

designed to take account of Council decision 2002/813/EC of

3 October 2002 establishing

summary notification information format for deliberate

release of GMOs into the environment

for purposes other than placing on the market, in accordance

with Directive 2001/18/EC.



If any other country in the European Union so requires, the

the regulator send a copy of the complete

the application there. Regulation (2010:1193).



section 10 Before the regulator decides on the licensing issue

It shall provide the general public and other interested parties the opportunity to

give its opinion.



The authority shall lay down in its regulatory area

procedures for the consultation procedure provided for in the first subparagraph. Routines

shall mean that interested are given reasonable time to leave

views.



11 § Before the regulator decides on the licensing issue

It shall draw up a proposal for a decision and give

The environmental protection agency to submit their comments on the proposal.



The authority shall also give genetic engineering Committee opportunity

to give its opinion on the proposal on the matter relating to a new or

previously untested organism, an organism that previously tested

added new properties or an organism referred to be deposited

out under significantly different conditions than in the past.

Regulation (2006:1504).



section 12 of the supervisory authority shall, where appropriate,

taking into account the views of other countries in the European Union,

decide in the matter within 90 days from the date of

the application was received.



For the purpose of calculating the 90-day period shall not be included with the

time when the regulator is waiting for information that the applicant has

before submitting or conducting consultations under 10 or

section 11.



Consultation must not lead to a 90-day period is extended with more

than 30 days.



Authorisation decisions



section 13 If the regulator gives permission to release to


any conditions which the State United with specified in

the decision.



section 14 of the regulatory authority shall inform the European

the Commission of the final decisions taken by the authority

reports in cases where permission to the deliberate release into the environment.

If an application is rejected, the Commission shall also

be informed of the reasons for the decision. Regulation (2010:1193).



Changing conditions and new information



section 15 this section applies in the case of the deliberate release into the environment as

covered by the State, or for which the licence has been applied for but

State the question pending, and



1. the licensee or applicant intends to change

activities,



2. circumstances changes relevant to the ongoing

or planned release, or



3. the new information relevant to the

the risk assessment.



If a change can be dangerous to human health or the

environment or if a new indication suggests that there is such a

risk, should the licensee or applicant immediately



1. take the necessary measures to protect human health

and the environment,



2. notification of the change or the new task to

the regulatory authority, and



3. ensure that the information on protective measures and other

precautions given in the application for the change or

updated in so far as they are relevant.



A licensee shall not implement a change that can

risk to human health or the environment without

first reported the change to the supervisory authority.



16 § after the notification referred to in section 15 has been made,

the supervisory authority shall evaluate the information received

forward. The same applies if the authority otherwise rated

knowledge of circumstances which may have a significant impact on

risks to human health or the environment.



If the new information raises it, the regulatory authority

decide that specific conditions shall apply for the business, to

operations shall be suspended indefinitely or to the business

no longer can be carried out.



Reporting on completion of release



17 § When a deliberate release into the environment have been carried out,

the licensee shall draw up a report on the results

the release received in terms of the risks to human health

or the environment. The report shall be submitted to the supervisory authority.

The licensee shall draw up and submit such

reports to the extent that the regulatory authority specified in

the conditions of the authorization.



If the licensee intends to later apply for authorisation to

the placing on the market of a product containing a

organism falling within the scope of the release, each

product type specifically mentioned in the report.



The supervisory authority may, within its regulatory area, to the

detailed rules relating to the formulation of the report required as a result

the decision referred to in article 10 of Directive 2001/18/EC.



section 18 of the regulatory authority shall inform the European

the Commission of the results as reported under section 17.

Regulation (2010:1193).



3 Cape. The placing on the market



Exemptions from the permit requirements



1 § provision of 13 chapter. section 12 of the environmental requirements

authorization for placing on the market or the provisions of

This chapter shall not apply when genetically modified

organisms are provided



1. for contained use within the scope of

the provisions of the Regulation (2000:271) on the contained

the use of genetically modified organisms,



2. only for deliberate release under this regulation,

or



3. for products placed in accordance with Council regulation

(EEC) No 2309/93 of 22 July 1993 laying down Community procedures

for the authorisation and supervision of

medicinal products for human and veterinary use and for

establishing a European Agency for the evaluation of medicinal products and the

places the product show that the conditions set out in

Article 12 (2) of Directive 2001/18/EC are fulfilled.



section 2 of the regulatory authority may, within its regulatory area Info

that some products consisting of, or

containing GMOs, which is placed

on the market are not subject to licensing in 13

Cape. section 12 of the Environment Act or the provisions of this chapter.



Such regulations may be notified only if the conditions

referred to in article 12 of Directive 2001/18/EC are fulfilled.



Application for authorization



paragraph 3 of the application form authorising the placing on the market shall

be made by the supervisory authority which is responsible on

prudential supervision. The Authority also examines issues of

State.



section 4 of the application for authorization shall include technical

data and other information to the extent that

specified in annexes 2 and 3, as well as such a risk assessment

referred to in Chapter 1. section 6. Conclusions of the risk assessment should

comply with the requirements of annex 1, section D.



In addition, an application must contain



1. a proposal for the conditions a licence decision

should be reconciled with, including specific conditions for

use and other handling of the product,



2. a proposal for the duration of the validity of

not more than ten years,



3. a monitoring plan, in accordance with annex 4, with

proposal for the time period to which the plan should include,



4. a proposal for labelling and packaging that meets the

the requirements of annex 3,



5. a summary of the technical information, designed

having regard to Council decision 2002/812/EC of 3 October

2002 establishing the summary

information format relating to the placing on the market of

products consisting of or containing genetically

modified organisms, in accordance with the European Parliament's

Directive 2001/18/EC, and



6. data from applications previously made or

made releases of the same GMOs

organism or a combination of genetically modified

organisms.



The supervisory authority may, within its regulatory area Info

detailed rules on the design of the summary,

regulations on the application of annex III to

as a result of EU decisions and rules on

the application of annex 4. Regulation (2010:1193).



5 § instead of submitting information may an applicant reference

to data or results from previous applications. A

reference to secret information in someone else's past

application may be made only if the prior applicant admitted it.



section 6 supervisory authority may, in the particular case give

exemption from the requirements for documentation in section 4, if such

dispensation



1. is compatible with the EU decision announced support of

Article 16 of Directive 2001/18/EC, or



2. relating to the requirements of annex 3, section (B) and the applicant shows

that the placing on the market does not present any risk to

human health or the environment.



The regulatory authority may inform the prescriptions needed

as a result of the European decision referred to in the first subparagraph 1.

Regulation (2010:1193).



Granting of permits



7 § When the regulatory authority has received an application to

the



1. send a confirmation of this to the applicant and specify

the date the application was received, and



2. immediately send a copy of the summary

referred to in paragraph 4 5 to the other countries of the

The European Union and to the European Commission.

Regulation (2010:1193).



section 8 regulatory authority shall check whether the requirements

to the provisions of article 4 are met and if the risk can

is considered real.



The regulatory authority may order the applicant to submit the

additional information required for the granting of permits.

Such injunction shall be motivated.



When the application complies with the requirements of section 4 shall

the regulator send a copy of the application to

Commission of the European communities. Regulation (2010:1193).



section 9, the regulatory authority shall draw up an assessment report.



In preparing the report, the supervisor shall follow

the guidelines set out in annex VI to Directive 2001/18/EC. Authority

shall give genetic engineering Board opportunity to comment on the application

refers to a new or previously untested organism or application

refer to the placing on the market under significantly different

conditions than in the past, the authority shall also provide

The environmental protection agency to submit their comments.



The assessment report shall indicate whether the regulator

recommend or oppose the placing on the market. If

authority is favourable to the placing, the report shall

also indicate the conditions that should apply to the placing.



section 10 of the regulatory authority shall be established and shall send

its assessment report to the applicant within 90 days of

that application was filed. If the authority has given a favourable opinion

the placing on the market, the authority shall, within the same time

submit the assessment report to the European Commission.

For the purpose of calculating the 90 day period shall not be included with the

time when the regulator is waiting for data

the applicant has submitted to the submission.



If the regulator has delivered a negative opinion on the

market, it shall submit the assessment report to

The European Commission no earlier than 15 days after the

the assessment report was sent to the applicant and no later than 15

days after the end of the 90-day period referred to in

the first paragraph. Regulation (2010:1193).



11 § When the regulatory authority sends its assessment report

to the European Commission, the authority shall attach any

information is the basis for the report and the

data relevant to the calculation of the 90

day period. If the copy of the application referred to in section 8

the third paragraph has not been submitted to the

the Commission, the copy will be sent together with the

the assessment report. Regulation (2010:1193).



section 12 Of the regulator in its assessment report has

on the placing on the market, the authority shall reject the

the application and state the reasons for the decision.



A notification of the decision shall be sent to the gene technology Committee

and the environmental protection agency.



section 13 Of the regulator in its assessment report has

ratified the placing on the market, the provisions of 14-

16 sections.




section 14 of the articles 14 and 15 of Directive 2001/18/EC are

provisions relating to proceedings in which the other countries of the

The European Union and the European Commission may request

additional information, give opinions and make

objections. If additional information is requested,

comments or objections are made or if it

any other reason needed further information for

permit consideration, the supervisory authority may submit to the

the applicant to submit the data. Such an injunction

shall be motivated. Regulation (2010:1193).



section 15 regulatory authority shall authorize the placing

on the market if



1. the lapse of 60 days ago the European Commission

sent out the assessment report to the other countries of the

The European Union, and



2. neither from any other country in the European Union

or the Commission has notified a reasoned

objection to the placing on the market.

Regulation (2010:1193).



section 16 if the conditions for authorization under section 15 does not

are met due to a reasoned objection has

notified to the supervisory authority concerned, consult

authorities in the other countries of the European Union and

with the European Commission. The deliberations should refer to:

to reach an agreement within 45 days after

the end of the 60-day period referred to in section 15.



If an agreement is reached within the time limit referred to in the first

subparagraph, the supervisory authority shall decide in

the licensing issue in accordance with the agreement.



If an agreement is not reached within the time limit referred to in

first subparagraph, the supervisory authority may authorise

the placing on the market only if a decision as

referred to in article 18 of Directive 2001/18/EC permits.

Regulation (2010:1193).



Authorisation decisions



section 17 A licence should contain



1. indication of the products covered by

the State, with an indication of the product or products

unique identifier and the data otherwise as

needed to identify the product (s),



2. indication of the period of validity of the authorization,



3. the terms and conditions that apply to the use, handling and

packaging as well as the conditions that otherwise needed to

protect human health and the environment,



4. conditions relating to the licensee on

regulator's request to provide samples for

control,



5. conditions concerning the labelling in accordance with annex III, and



6. conditions concerning monitoring in accordance with annex IV,

including the obligation to report to the other

the countries of the European Union and to the European

the Commission. Regulation (2010:1193).



section 18 If the regulator decides to authorize, should

the within 30 days send a notification of the decision to

the applicant, to the other countries of the European Union and

to the European Commission.



While genetic engineering Committee and the environmental protection agency should

be informed. Regulation (2010:1193).



section 19 Of chapter 13. section 17 of the environmental code, it appears that a State

valid for five years unless otherwise stated in the permit decision.



An authorization may be given for a maximum period of ten years from

the date of the permit decision.



The regulatory authority may decide that the licence shall be valid

For more than ten years if the decision relates to the marketing of

agricultural plant species or of vegetable species referred to in Annex i to

utsädesförordningen (2000:1330) or such basic material

covered by the official national register of approved

seed sources according to the forestry law (1979:429). The authorisation may

not be given for longer than necessary to plant or

the basic material to be approved according to the rules.



Application for renewal of authorisation



section 20 of The authorised for placing on the market can

apply for the authorization to be renewed. An application for renewal

a permit shall be filed with the regulatory authority no later than nine

months before the former given expires.



section 21 An application for renewal of the licence shall contain:



1. a copy of the previous permit given to placing

on the market,



2. a report on the results of the monitoring carried out in

under the terms of the previous authorization,



3. all new information arrived regarding the

risks to human health or the environment, as well as



4. a draft of the amendments or additions to the

the conditions of the permit required in connection with the renewal.



The examination of the application for renewal of authorisation



section 22 When the regulatory authority has received an application for

renewal of licence, the applicant to send an acknowledgement

on this and enter the date on which the application was received.



section 23 of the GMOs covered by State

to the placing on the market shall, after the application for renewal of the

permission has been submitted, continue to be placed on the market

until the issue of the renewal of the permit has finally been settled.



section 24 of the regulatory authority shall examine whether the application complies with the

the requirements of section 21 and shall draw up an assessment report.



In preparing the report, the supervisor shall give

Genetic Engineering Board opportunity to comment On the renewal of the

State means the placing on the market for substantially

different conditions than in the past, the authority shall also provide

The environmental protection agency to submit their comments.



The assessment report shall indicate whether the regulator

recommend or oppose to the permit is renewed. If

authorities recommend a renewal shall also report

indicate the conditions that should apply to continued placing on

the market.



paragraph 25 of the supervisory authority shall without delay send a copy

of the assessment report to the applicant and to the European

the Commission. To the supervisory authority, the Commission shall

also send a copy of the application for renewal of the authorization.

Regulation (2010:1193).



section 26 of the supervisory authority shall act in accordance with its

assessment in the assessment report, if



1. the lapse of 60 days ago the European Commission

sent out the assessment report to the other countries of the

The European Union, and



2. neither from any other country in the European Union

or the Commission has notified a reasoned

objection to the proposal in the assessment report.

Regulation (2010:1193).



27 § on the conditions for decision pursuant to section 26 is not

met due to a reasoned objection has been notified

the provisions of sections 28 and 29 shall apply.



section 28 Of the regulator in its assessment report has

approved the renewal of the licence, the authority shall

consult with the appropriate authorities in the other countries of the

The European Union and with the European Commission.

The negotiations will aim at reaching an agreement

within 15 days after the end of the 60-day grace period that

referred to in section 26. If an agreement is reached within this time limit,

the authority shall decide on the issue of the permit in accordance with

the agreement. Regulation (2010:1193).



section 29 on the conditions for decision pursuant to section 28 is not

fulfilled, or if the supervisory authority of

the assessment report has delivered a negative opinion a renewed permit,

the authority shall decide, in accordance with such a Europe-

decision referred to in article 18 of Directive 2001/18/EC.

Regulation (2010:1193).



Decision on the renewal of the authorisation



section 30 a decision to give renewed authorization for placing on the

the market must contain the information and conditions specified in

17 §.



The provisions of section 18 of the notice shall apply also in

case of decisions referred to in 26, 28 and 29 sections.



Of 13 chapter. section 17 of the environmental code, it appears that a State applies in

five years unless otherwise stated in the decision. Renewed authorisation may

be given for longer than 10 years only if there are special

reasons. If the renewal of the authorisation for short or long time

than ten years, shall state the reasons for the time specified in the decision.



Monitoring and reporting



section 31 When a product has been placed on the market shall

the licensee shall ensure that monitoring and reporting are carried out

According to the terms you set up in the permit decision.



paragraph 32 Of annex 4 shows that the results of the monitoring shall be

reported with certain intervals. Since the first report

submitted to the regulator, it may change

the conditions for supervision. Such a conditional amendment shall be made

with regard to what was revealed in the report, and shall be

consistent with the authorization and accommodated within existing

monitoring plan.



New data



33 § the following applies with regard to the placing on the market

covered by the State, or for which a permit has been applied for but

the licensing issue has not yet been decided. If it comes up with a new

indication that a genetically modified organism within the scope of

placing can pose a risk to human health or the

environment, licensee or applicant immediately



1. take the necessary measures to protect human health

and the environment,



2. notify the new task to the regulatory authority, and



3. ensure that the information on the conditions, safeguards and

other precautions given in the application for the change

or updated in so far as they are relevant.



section 34 If the supervisory authority is informed of such a new

indication referred to in section 33, the authority shall immediately

inform the other Member States of the European Union and

Commission of the European communities. Regulation (2010:1193).



section 35 Of the regulator learned of the new task

before the permit issue has been settled, the new task

be considered in the context of the review procedure referred to in

14-16 sections as well as in §§ 26 and 28.



If the regulator learned of the new task after

that permission has been given, the provisions of §§ 36-42.



section 36 where an authorization for placing on the market has been

or renewed and the supervisory authority is informed of such

new task referred to in section 33, the authority shall update the

the assessment report referred to in section 9 or 24.



To update the report shall provide the supervisory authority

Genetic engineering and the environmental protection agency to submit their comments.




The updated assessment report shall indicate whether the

the supervisory authority is of the opinion that the authorization should be repealed

or if the licence conditions should be amended and, if so, in which

way the terms should be changed.



37 § regulatory authority shall send the updated

the assessment report to the European Commission within 60

days from the date that the Agency became aware of the new

task. Regulation (2010:1193).



section 38 supervisory authority shall act in accordance with its

assessment of the updated assessment report, if



1. the lapse of 60 days ago the European Commission

sent out the assessment report to the other countries of the

The European Union, and



2. neither from any other country in the European Union

or the Commission has notified a reasoned

objection to the authority.

Regulation (2010:1193).



39 section on the conditions for decision pursuant to section 38 is not

met due to a reasoned objection has been notified

the provisions of §§ 40 and 41 shall apply.



section 40 Of the regulator in its updated

assessment report has not taken the view that the State should

to expire, the authority shall consult with the relevant

authorities in the other countries of the European Union and

with the European Commission. The deliberations should refer to:

to reach an agreement within 15 days of

the end of the 60-day period referred to in section 38. If a

agreement is reached within this time limit, the

the regulatory authority may decide, in accordance with

the agreement. Regulation (2010:1193).



section 41 if the conditions for decision under section 40 is not

fulfilled, or if the supervisory authority of its

assessment report has taken the view that the State should stop

to be valid, the authority shall decide, in accordance with a

such a European decision referred to in article 18 of Directive

2001/18/EC. Regulation (2010:1193).



42 § provisions of section 18 of the notice shall apply

also in the case of decisions referred to in 38, 40 and 41 sections.



Mutual recognition



section 43 If a product in another country of the European Union is

approved for placing on the market and that the authorisation has

been made in accordance with rules corresponding to the provisions of this

Regulation, the product may be placed on the market in Sweden

without specific authorization under Chapter 13. section 12 of the environmental code and

Notwithstanding the provisions of 3-42 of this chapter.



The first paragraph is only valid if the placing is in compliance with the

specific terms of use and the requirements for environments

or geographical areas which approval is associated with.



Temporary restrictions and prohibitions



44 section where for a product covered by the authorization

in accordance with the provisions of this chapter or of a corresponding

approval in another country of the European Union will arrive

new information justified to assume that the product

pose a risk to human health or the environment, the

the supervisory authority temporarily to restrict or prohibit

the product's use or sale in Sweden.



If the risk is serious, the supervisory authority shall ensure that

the measures necessary for the protection of human health

and the environment.



section 45 If the regulator decides on temporary

limitation or prohibition under section 44, the authority shall

immediately notify the other Member States of the European

Union and the European Commission if they decided

the measures and the reasons for them. The notification should

contain the new risk assessment made by the authority and

an account of the new information which led to the

the decision.



The notification shall indicate if the regulator considers

permit or authorisation in force should be repealed

or if conditions should be changed and if so, in what way

conditions should be changed. Regulation (2010:1193).



4 Cape. Marking, registration and public information



Labelling



section 1 in Chapter 3. section 17 is a provision concerning the labelling of products

placed on the market. If a product is placed on the

the market on the basis of approval in another country of the European

Union, the product shall be marked in accordance with the conditions set out

in the authorisation.



Products referred to in Chapter 3. 1 § 1 and 2 shall be marked in

accordance with annex III to this regulation, in the parts the annex

is relevant for such products are granted. The label shall contain

appropriate recommendations for, and restrictions on the use of

product. It shall state that the product contains genetically

modified organisms (GMOs).



In the case of a product that is intended for the direct processing

the first subparagraph or the conditions on labelling referred to

in Chapter 3. 17 section 5 does not apply to traces of authorised genetically

If the tracks



1. do not exceed 0.9 percent of the product, and



2. is adventitious or technically unavoidable.

Regulation (2006:1504).



section 2 of the regulatory authority may, within its regulatory area, to the

additional regulations on labelling may be necessary

as a result of articles 21 (2) and 26 (2) of Directive 2001/18/EC.



Registration



section 3 in order to facilitate supervision, the supervisory authority,

within its regulatory area, establish register of



1. sites used for the deliberate release into the environment with the support of

This regulation and



2. sites in Sweden where the cultivation of products

containing or consisting of genetically modified organisms and

placed on the market on the basis of an authorization pursuant to this

Regulation or equivalent approval in another country in

The European Union.



4 § The producing products referred to in section 3, paragraph 2 shall ensure that

places where cultivation is reported to the responsible supervisory authority.



The supervisory authority may, within its regulatory area Info

details relating to such notification.

Regulation (2006:1504).



Information to the public



section 5 of the supervisory authority responsible within its regulatory area

for the general public information on



1. decisions of the supervisory authority referred to in Chapter 2. 12 and 16 §§

and 3 the Cape. 15, 16, 26, 28, 29, 38, 40, 41 and 44 § §,



2. The European decision referred to in Chapter 3. 16, 29 and 41 sections,



3. the information referred to in Chapter 2. paragraph 16,



4. the results of the release and supervision provided

in Chapter 2. section 17, Chapter 3. section 31,



5. the records referred to in Chapter 4. section 3, and



6. such a release as referred to in Chapter 5. 7 §.

Regulation (2010:1193).



Chapter 5. Other provisions



Union procedures



section 1 of the regulator is within its regulatory area it

Swedish competent authority referred to in

Directive 2001/18/EC. In this capacity, the Agency may, in

respect of matters in accordance with the provisions of the directive

processed in another country of the European Union or of the

The European Commission



1. request a copy of an application or request additional

data,



2. make comments or reasoned objections,



3. make proposals for the decisions referred to in

articles 7 and 16 of Directive 2001/18/EC, and



4. request the Commission to consult a scientific

or with an Ethics Committee in the situations referred to in

articles 28 and 29 of Directive 2001/18/EC.

Regulation (2010:1193).



2 § When a regulatory agency has been notified of an application for

the placing on the market, which has been made in another country in

The European Union, it shall promptly inform the Government

this.



The Government may reserve the decision on the issue of a

motivated objection shall be made. Regulation (2006:1504).



3 § If the Government does not have reserved the decision under

section 2 of the supervisory authority, within its regulatory area, shall notify

a reasoned objection in accordance with paragraph 1 of the 2, if the authority of a

under Chapter 13. 13 § compared to Chapter 2. the environmental code

considers that it is not in a position to give permission

the placing on the market of the product.



Before the regulator determines whether an objection shall be notified,

It shall give genetic engineering Committee to submit their comments.

The Agency shall also provide the environmental protection agency to submit their comments

in the case of applications relating to a new or previously

untested organism or placing on the market in

significantly different conditions than in the past.

The environmental protection agency will also have the opportunity to give its opinion in the case

If reconsideration due to new information on risks.



Reporting to the European Commission



section 4 of the regulatory authority shall, within its regulatory area,

fulfil the reporting to the European Commission that

referred to in articles 11(4) and 31.4 of Directive 2001/18/EC.

Regulation (2010:1193).



Transboundary movement of genetically modified

organisms



4 AOF the environmental protection agency to coordinate the national work

with Sweden's participation in the international

the information procedure laid down in Regulation (EC) no 1946/2003.



Regulatory authorities shall communicate to the

The environmental protection agency under article 15(1) thereof.

Regulatory authorities shall consult with the environmental protection agency on how

data shall be provided. Regulation (2006:1504).



Cooperation with the countries of the European economic area



paragraph 5 of the present regulation, how about other countries in

The European Union shall also apply in relation to

Iceland, Norway and Liechtenstein, as regards the provisions on



1. sending of a copy referred to in Chapter 2. section 9, and Chapter 3. 7 § 2,



2. notification of the decision referred to in Chapter 3. 18, 30 and 42 sections,



3. notification of a new task referred to in Chapter 3. § 34,



4. notification of restrictions and prohibitions in accordance with Chapter 3.

§ 45,



5. the regulator's jurisdiction under Chapter 5. 1 § 1 and 2

and section 2, and



6. notification of release into the environment without authorization pursuant to 5

Cape. 7 §.



Supervision



section 6 of the Regulations on supervision, see 26 Cape. the Environment Act and in

environmental protection Regulation (2011:13). Provisions on the

operational supervisory responsibilities associated with this regulation

see Chapter 2. 4 and 13 to 18 of regulation for environmental inspections.

Regulation (2011:37).



section 7 If a genetically modified organism is put out or a

product consisting of or containing genetically


modified organism is placed on the market without

permission has been granted in accordance with this regulation, shall

the regulatory authority shall take the measures necessary to

situation in accordance with chapter 26. the environmental code.



The authority shall also inform the other countries of the

The European Union and the European Commission on the

occurred. Regulation (2010:1193).



Fees



section 8 of the Ordinance (1998:940) on fees for examination and

supervision under the Environment Act contains provisions relating to fees.



section 9 of the Regulation (2012:259) on miljösanktions fees are

provisions on miljösanktions charges.

Regulation (2012:260).



Appeal and penalty and forfeiture



section 10 of the 19 Cape. § 1 and 29 Cape. the Environment Act contains provisions

on appeal, as well as penalties and forfeiture.



Entry into force and transitional provisions



2002:1086



1. This Regulation shall enter into force on 17 January 2003 when

Ordinance (1994:901) on genetically modified organisms

ceases to be valid.



2. applications for deliberate release or the placing on

the market made before 17 January 2003 not yet

pending at the time of its entry into force, shall be dealt with in accordance with

the new regulation.



3. Authorization for placing on the market as referred to in older

provisions made before 17 October 2002, before the 17

October 2006 renewed according to the provisions of Chapter 3. 21-30 of,

If the application for renewal of a licence shall be submitted to the

the regulatory authority prior to the October 17, 2006.



Annex 1



Principles of risk assessment



This annex describes the objectives to be achieved with the

risk assessment referred to in Chapter 1. section 6 of the Ordinance (2002:1086)

on the release of GMOs into the environment. In

the annex also describes the factors to be taken into account as well as the

General principles and methodology to be followed when

the risk assessment is done.



For the purposes of this annex, taking into account what is

the provisions of Commission decision 2002/623/EC of 24 July 2002 on

guidance notes to supplement annex II to

European Parliament and Council Directive 2001/18/EC on the deliberate

release of GMOs into the environment and the

repealing Council Directive 90/220/EEC.



For the purposes of this annex



-direct effects "refers to primary effects on human health or the

environment which can be attributed directly to a genetically modified

organism and not through a series of interrelated causes,



-indirect effects "refers to effects on human health or the environment

that can be traced back to a genetically modified organism by a

series of interrelated causes, through mechanisms such as.

interactions with other organisms, transfer of genetic

materials or changes in use or management

(observations of indirect effects are likely to be

delayed),



-immediate effects "refers to effects on human health or the

the environment which are observed during the period in which genetically modified

organisms are set out (immediate effects may be direct or

indirect),



-delayed effects "refers to effects on human health or the environment

that may not be observed during the period of genetically

modified organisms are put out but which turns out as a direct

or indirect effect either at a later stage or when

the release has been completed,



-cumulative long-term effects "refers to the accumulated effects of

a State may have on human health or the environment

including, among other things. flora and fauna, soil fertility, soil

decomposition of organic matter, the food chain, the

biodiversity, animal health and resistance problems in

the course of antibiotics,



-higher plants "means plants which belong to the taxonomic group

Spermatophytae (gymnospermae and Angiospermae).



A. Objectives



The objective of risk assessment, on a case by case basis

identify and evaluate the potential adverse effects of a

the deliberate release or the placing on the market of

genetically modified organisms can have on human health

or the environment. The negative effects can be direct or

indirect, immediate or delayed. The risk assessment should

be done to investigate if there is a need for risk management and in

If so which methods are most appropriate.



B. General principles



The risk assessment shall be carried out an analysis of the different

effects, including cumulative long-term effects, which are

together with the release or placing on the market.



In addition, should, in accordance with the precautionary principle, the following

General principles to be followed when the risk assessment is done:



-Identified characteristics of the genetically modified

organism and its use, which may result in adverse

effects, should be compared with those of the non-

modified organism from which it is derived and

the use of these in the appropriate situations.



-The risk assessment should be carried out in a scientifically sound and transparent

manner and be based on available scientific and technical

data.



-The risk assessment should be made on a case by case basis. The

the required information may vary depending on the type of

the GMOs concerned, their intended

use and the environment, if any, to take against them.

In doing so, shall take into account, among other things. the genetically modified organisms

already exists in the environment.



-If new information on the GMO and its

effects on human health or the environment becomes available,

the risk assessment may need to be repeated to determine if the level of risk

has changed or if there is a need to change the

risk management.



C. Methodology



C.1. characteristics of GMOs and

releases



The risk assessment must, depending on the circumstances of the

individual case, be taken into account the relevant technical and scientific

facts about the characteristics of



-the recipient or parental organism,



-genetic manipulation (through the introduction or removal of

genetic material) including relevant information on the vector

and the dealer,



-the GMO;



-the release or use, including

purpose or scope of use,



-the potential receiving environment, and



-the interaction between these.



Information from releases of similar organisms and organisms

with similar traits and their interaction with similar

environments can be helpful for risk assessment.



C. 2 Different steps of risk assessment



The risk assessment should lead to conclusions regarding the

the following.



1. Identification of characteristics which may cause adverse

effects



In a risk assessment shall be identified all the properties of

genetically modified organisms which are attached to the

genetic modification and that can lead to adverse effects

to human health or the environment. The identification of such

negative effects can be facilitated when comparing

the characteristics of one or more genetically modified

organisms and the characteristics of the corresponding non-

modified organism under corresponding withdrawal-and

terms of use. It is important not to ignore any

possible negative effect on the grounds that it is unlikely

the effect occurs.



The possible adverse effects of genetically modified

organisms vary from case to case, and may include:



-disease to humans including allergenic or

toxic effects (see for example Appendix 2 (A), section II A, item 11

and section II C paragraph 2 and annex II B, section B, paragraph 7),



-disease to animals and plants and, where appropriate,

allergenic effects (see, for example, annex 2 (A), section II (A)

section II, paragraph 11 (C) and paragraph 2 and annex II B, section B

paragraph 7 and section D paragraph 8),



-effects on population dynamics within and between species in the

receiving environment and the genetic diversity within each

of these populations (see for example Appendix 2 (A), section IV (B)

paragraphs 8, 9 and 12),



-modified susceptibility to pathogens facilitating the dissemination

of infectious diseases or create new reservoirs or

vectors,



-Adventure spirit of the medical, veterinary and plant-health treatments

in prophylactic or therapeutic purposes, for example. as a result of

transfer of genes conferring resistance to antibiotics

used in human or veterinary medicine (see, for example, annex 2

A, section II, paragraph 11 (e) and section II (C) of paragraph 2,

under item (iv)),



-effects on Biogeochemistry (biogeochemical cycles), particularly

carbon and nitrogen recycling through decomposition of

changes in soil organic matter (see, for example, annex 2 (A),

section II, paragraph 11 (f) and section IV (B) paragraph 15 and annex 2

(B), section D, paragraph 11).



Adverse effects may occur directly or indirectly through

mechanisms which may include:



-the spread of the GMO (s)

in the environment,



-the transfer of the inserted genetic material to other

organisms, or the same organism whether

genetically modified or not,



-phenotypic and genetic instability,



-interaction with other organisms, or



-change management, for example. changes in agricultural practices.



2. Evaluation of the potential consequences of each adverse

effect



The extent of the consequences that may result from any

possible negative effect should be evaluated. At this evaluation should

We assume that such an adverse effect will occur.

Impact extent is influenced by the environment in which

It is intended to set out one or more genetically modified

organisms and of how the release is implemented.



3. evaluation of the likelihood that an identified

any adverse effect must occur



When evaluating whether it is reasonable or likely that a

negative impact occurs, it is important to take into account

the characteristics of the environment in which the release of one or more

genetically modified organisms (GMOs) are intended to be done and how

release is implemented.



4. Estimation of the risk posed by each identified characteristic of


the GMO (s) is



An estimate of the risk to human health or the environment,

be made in the case of each identified characteristic of the GMO

modified organism that can cause adverse

effects. This estimate shall be made in the light of

latest scientific findings. When the estimate is made,

the likelihood of the adverse effect occurring is combined

with the extent of the consequences that would follow if

the impact occurred.



5. Application of management strategies for risks from the deliberate

release or placing on the market of one or more

genetically modified organisms (GMOs)



Risk assessment makes it possible to identify risks

demand management as well as the ways in which the risks are best

are handled. A risk management strategy should be defined.



6. Determination of the overall risk of one or more

genetically modified organisms (GMOs)



An evaluation of the overall risk of one or more

genetically modified organisms should be made taking into account the

any risk management strategies which are proposed.



D. conclusions on the potential environmental impact resulting from

the release or the placing on the market of genetically

modified organisms



In the light of the risk assessment shall be carried out in accordance with the

principles and methodology set out in section (B) and (C), should

information in the ways listed in sections d.1 and d.2

be included in the applications. The data will serve as a help

then the conclusions shall be drawn in terms of potential environmental impact

as a result of genetically modified organisms (GMOs) are set out in

the environment or placed on the market.



D.1 Other genetically modified organisms other than higher plants



1. Likelihood of the GMO

becomes resistant and invasive in natural habitats under the

the conditions of the proposed release (s).



2. Any selective advantage or disadvantage conferred to the

GMO and the likelihood of

These are realised under the conditions of the proposed

release (s).



3. Potential for gene transfer to other species under conditions

for the proposed release of the genetically modified

organism, and any selective advantage or disadvantage that when

assigned to these species.



4. Potential immediate and/or delayed environmental impact

by direct or indirect interactions between genetically

modified organism and target organisms (if applicable).



5. Potential immediate and/or delayed environmental impact

by direct or indirect interactions between genetically

modified organisms and non-target organisms. Herein are included

impact on population levels of competitors,

preys, hosts, symbionts, predators,

parasites and pathogens.



6. Possible immediate and/or delayed effects on human

health resulting from potential direct and indirect

interactions of the GMO and

persons working with, coming into contact with or in the

close to the release of genetically modified organisms.



7. Possible immediate and/or delayed effects on animal health

and consequences for the feed/food chain resulting from consumption of

the GMO and products

derived from it, if it is intended

to be used as animal feed.



8. Possible immediate and/or delayed effects on biogeochemical

processes resulting from potential direct and indirect

interactions of the GMO and

target or non-target organisms in the vicinity of the or

several releases of genetically modified organisms.



9. Possible immediate and/or delayed, direct or indirect

environmental impacts of the specific techniques used

for the management of the GMO where these are

methods are different from those used for non-genetically

modified organisms (GMOs).



D. 2 Genetically modified higher plants (GMHV)



1. The likelihood that an GMHV becomes more resilient than

the recipient or parent plant in agricultural environments,

or more invasive in natural habitats.



2. Any selective advantage or disadvantage conferred to the GMHV.



3. Potential for gene transfer to the same or other sexually

compatible plant species when the conditions for planting by GMHV is followed

and any selective advantage or disadvantage conferred to those

plant species.



4. Potential immediate and/or delayed environmental impact

of the direct and indirect interactions between GMHV and

target organisms, such as predators, parasitoids, and pathogens (in

If applicable).



5. Possible immediate and/or delayed environmental impact of the

direct and indirect interactions between GMHV and non-

target organisms, also taking into account organisms which interact with

target organisms. This included impact on population levels

of competitors, herbivores, symbionts (where applicable

case), parasites and pathogens.



6. Possible immediate and/or delayed effects on human

health resulting from potential direct and indirect

interaction between GMHV and persons working with, coming into

contact with or in the vicinity of one or more

releases of GMHV.



7. Possible immediate and/or delayed effects on animal health

and consequences for the feed/food chain resulting from consumption of

GMHV and of products derived from GMHV, if they are intended

to be used as animal feed.



8. Possible immediate and/or delayed effects on biogeochemical

processes resulting from potential direct and indirect

interaction between GMHV and target, as well as non-

target organisms in the vicinity of one or more releases of

GMHV.



9. Possible immediate and/or delayed environmental impact of the

the specific methods used to cultivate, manage, and

harvest GMHV, where these are different from those used

for non-GMHV.



Annex 2



Information required in the application



An application for an authorisation for the deliberate release or

the placing on the market within the meaning of the Ordinance (2002:1086) if

release of GMOs into the environment, in

If applicable, contain the information set out in

in annexes II A and II B.



The information referred to in annexes II A and II B are mandatory

to the extent that they are relevant and necessary for the examination of

the cases in question.



The application must be made a description of the methods used

in examinations or a reference to the

standardised or internationally recognised methods

been used. The name of the body or bodies responsible for

the studies shall also be indicated.



Annex 2 (A) shall apply to releases of all types of

genetically modified organisms other than higher plants. Annex 2 B

applies to releases of genetically modified higher

plants.



The term "higher plants" means plants which belong in this annex

to the taxonomic group Spermatophytae (gymnospermae and

Angiospermae).



Annex II A



Information required in the application for the release of other

genetically modified organisms other than higher plants



I. General information



A. the applicant's (company, institution or equivalent) name and

address.



B. The name of the responsible researcher, education and

experience.



C. project name.



II. Information relating to the GMO



A. characteristics of (a)) the donor, (b)) the recipient or

c) parental organism (s), if available



1. scientific name.



2. Taxonomy.



3. other names (usual name, strain name, etc.).



4. Phenotypic and genetic markers.



5. Degree of relatedness between donor and recipient or

between parental organisms.



6. Description of identification and detection techniques.



7. sensitivity of detection and identification techniques,

reliability (in quantitative terms) and specificity.



8. Description of the geographical distribution of the organism and

natural habitat of the plant, including information on natural

predators, preys, parasites and competitors,

symbionts and hosts.



9. Organisms with which it is known that transfer of genetic

materials occurs under natural conditions.



10. verification of the genetic stability of the organisms and

factors that affect this.



11. pathological, ecological and physiological traits:



a) classification of hazard according to existing Community rules concerning the protection of

human health and the environment.



(b)) Generation length in natural ecosystems, sexual and asexual

reproductive cycle.



c) information on survival, including adaptation to

seasonal and the ability to form survival structures.



d) Pathogenicity; infectivity, toxicity, virulence and

allergenicity, carrier (vector) of pathogen, possible vectors,

range of host range including non-target organisms, possible

activation of latent viruses (provirus). Ability to colonize

other organisms.



e) antibiotic resistance, and potential use of these

antibiotics for prophylaxis and treatment of people.



f) involvement in environmental processes; primary production,

nutrient turnover, decomposition of organic matter,

respiration, etc.



12. Nature of indigenous vectors:



a) Sequence.



(b)) frequency of mobilisation.



c) specificity.



(d)) the presence of genes that transfers resistance.



13. History of previous genetic modifications.



B. characteristics of the vector



1. Nature and source of the vector.



2. Sequence of Transposons, vectors and other non-coding

genetic segments used to construct a certain

genetically modified organism and to ensure that the

the vector and the inserted function in the GMO.



3. frequency of mobilisation of inserted vector and/or capability to

transferring genetic material and methods for determining

this.



4. Information on the degree to which the vector is limited to the


the DNA required to perform the intended function.



C. characteristics of the modified organism



1. Information relating to the genetic modification.



a) methods used for the modification;



b) methods used to construct and introduce the or

the current DNA sequences in the receiver or to remove

a sequence.



c) description of the introduced genetic material or vector

building.



d) purity of the Insert from any unknown sequence and

information on the degree to which the inserted sequence is

limited to the DNA required to perform the intended function.



e) Methods and criteria used for selection.



f) sequence, functional identity and location of the

changed, inserted, or deleted nucleic acid segment (s), with

particular reference to any known harmful

sequence.



2. Information on the final GMO:



a) description of genetic trait (s) or phenotypic characteristics and in

especially those new traits and characteristics which may be expressed or not

longer expressed.



b) structure and amount of the nucleic acid from a vector or

donors still present in the modified organism final

construction.



(c)) the organism's genetic stability.



(d) ") content and amount of expression of the new genetic material

as well as the method of measurement and its sensitivity.



(e)) the expressed protein activity.



f) Description of identification and detection techniques

including methods for identification and detection of the inserted

sequence and vector;



g) sensitivity of detection and identification techniques,

reliability (in quantitative terms) and specificity.



h) history of previous releases or uses of

the GMO;



I) account of human and animal health and plant protection:



I) Toxic or allergenic effects of the GMOs

modified organisms or their metabolic products.



II) comparison of the modified organism to the donor,

recipient or (where appropriate) parental organism regarding

pathogenicity.



III) colonisation ability.



IV) if the organism is pathogenic to humans who are a working

immune system:



-Diseases caused and pathogenic mechanism including

invasiveness and virulence.



-Degree of infectivity.



-Infectious dose.



-Range of hosts, possible changes.



-Ability to survive outside the human host.



-Presence of vectors or means of dissemination.



-Biological stability.



Patterns of antibiotic resistance.



-Sensitisation.



-Existing appropriate methods of treatment.



v) other risks associated with the product.



III. Information relating to the conditions of release and the receiving

environment



A. Information about the release:



1. Description of the proposed deliberate release,

including the purpose and expected products.



2. Planned release dates and a time schedule for the

try specifying the frequency and

duration.



3. Preparations relating to the site of release.



4. Size of the site.



5. Withdrawal methods.



6. the quantity of genetically modified organisms must be

out.



7. Disturbance on the site (type and method of cultivation, mining,

irrigation, or other activities).



8. Worker protection measures taken during the release.



9. Post-release treatment of the site.



10. Techniques foreseen for elimination or inactivation of the

genetically modified organisms (GMOs) at the end of the experiment.



11. information on, and results of previous releases of the same

genetically modified organisms, in particular, releases

carried out in different scale and in other ecosystems.



B. information on the environment (both on the site and in its

surroundings)



1. Release site-their geographical

location with reference to the grid map (at

applications under part C corresponds to release will be the

areas where the product is intended to be used).



2. Physical or biological proximity to humans and other

significant biota.



3. Proximity to significant biotopes, protected areas, or

drinking water supplies.



4. Climatic characteristics of the regions which may be

are affected.



5. geographical, geological and pedological characteristics.



6. Flora and fauna, including crops, livestock and migratory

species.



7. Description of target and non-target ecosystems that can

be affected.



8. A comparison of the natural habitat of the recipient organisms '

proposed site (s) of release.



9. Known planned developments or changes in

land use in the region which could affect

environmental impact of the release.



IV. Information relating to the interactions between genetically modified

organisms and the environment



A. Characteristics affecting survival, multiplication and distribution



1. Biological features which affect survival, multiplication and

spread.



2. Known or predicted environmental conditions which may affect the

survival, multiplication and distribution (wind, water, soil,

temperature, pH, etc.).



3. Sensitivity to specific agents.



B. interactions with the environment



1. Predicted Habitat of the GMOs

the organisms.



2. studies of the behaviour and characteristics of the

genetically modified organisms and the ecological impact

carried out in simulated natural environments, such as microcosms,

growth Chamber or greenhouse.



3. Genetic transfer capability:



(a)) Transfer of genetic material from genetically modified

organisms into organisms in affected ecosystems after

the release.



b) transfer of genetic material from indigenous

organisms to the GMOs after

the release.



4. Likelihood of postrelease selection leading

to unexpected or undesirable traits in the

modified organism.



5. Measures to ensure and to verify genetic

stability. Description of genetic traits, which can prevent

or restrict the dissemination of genetic material. Methods to

Verify genetic stability.



6. Biological Pathways as well as known or potential

interaction with the spread, for example. inhalation, ingestion,

face contact, penetration, etc.



7. Description of ecosystems to which the

genetically modified organisms could be achieved.



8. Potential for excessive population increase in the environment.



9. Competitive advantage of the GMOs

in relation to the unmodified recipient or

parental organisms.



10. Identification and description of the target organisms (in

If applicable).



11. Expected progress and results of the interaction between

genetically modified organisms which are set out and

the target organisms (if applicable).



12. Identification and description of non-target organisms

be adversely affected by the release of the genetically modified

organism, and expected progress for identified adverse

interaction.



13. The probability of shifts in biological interactions

or in the spectrum of postrelease.



14. Known or predicted interactions with non-target organisms in the

the environment, including competitors, preys,

hosts, symbionts, predators, parasites and

pathogens.



15. Known or predicted involvement in biogeochemical processes.



16. other potential interactions with the environment.



V. information on monitoring, control, waste treatment and

emergency response plans



A. Monitoring Methods



1. Methods for tracing the GMOs, and

to monitor their effects.



2. Specificity (to identify the

the GMOs, and to distinguish them from

the donor, recipient or, where appropriate, the parental organisms),

sensitivity and reliability.



3. Techniques for detecting transfer of the donated

genetic material to other organisms.



4. Duration and frequency.



B. Control of the release



1. Methods and procedures to avoid or limit

the spread of the GMOs beyond

the site of release or the designated area for use.



2. Methods and procedures to protect the site from intrusion

by unauthorized persons.



3. Methods and procedures to prevent other organisms

penetrating on the site.



C. Waste Treatment



1. Type of waste generated.



2. Expected amount of waste.



3. Description of planned waste management.



D. emergency response plans



1. Methods and procedures to make sure the genetically

modified organisms at the unexpected proliferation.



2. Methods for decontamination of the areas affected, for example.

eradication of the GMOs,



3. Methods for disposal or sanitation of plants, animals,

Earth, etc., that were exposed during or after the

the spread.



4. Methods for the isolation of the area affected by

the spread.



5. Plans for protecting human health and the environment if

occurrence of an undesirable effect.

Regulation (2010:1193).



Annex 2 B



Information required in the application for release of genetically

modified higher plants (GMHV)



A. General information



1. The applicant's (company, institution or equivalent) name and

address.



2. The name of the responsible researcher, education and

experience.



3. Title of the project.



B. information relating to (a)) the recipient or (b)) the parent plants (in

If applicable)



1. Full name:



(a)) family.



b) Genus.



c) Art.



d) Subspecies.



e) Plant/processing line.



f) common name.



2. a) information concerning reproduction:



I) mode (s).



II) specific factors affecting reproduction.



III) Generation length.



b) Sexual compatibility with other cultivated or wild

plant species, including compatible species distribution in Europe.



3. Survivability:




a) ability to form structures for survival or

germination rest.



(b)) any special factors that affect

survivability.



4. dissemination:



a) ways and extent (for example an estimation of how

viable pollen and/or seeds declines with distance).



b) specific factors affecting dissemination, if any.



5. Geographical distribution.



6. in the case of plant species not normally grown in Sweden or in

any other country in the European Union: A description of its

natural habitat of the plant, including information on natural

predators, parasites, competitors and symbionts.



7. Other potential interactions, related genetically

modified organism, with organisms in the ecosystem where the

usually grown, or elsewhere, including information on

toxic effects on humans, animals and other organisms.



C. information relating to the genetic modification



1. Description of the methods used for the genetic

modification.



2. Nature and source of the vector used.



3. Size, source (name) of donor organism or

the organisms and intended function of other elements of the

region that is intended to be introduced.



D. information relating to the genetically modified plant



1. Description of the characteristics which have been introduced or

modified.



2. information on the sequences actually inserted or

removed:



a) size and structure of the insert and methods used

for description of the plant, including information on any parts of the

vector introduced in GMHV, any carrier or foreign DNA

remaining in the GMHV.



(b)) the size and function of the deleted region (s).



c) copy number of the Insert.



(d)) the recorded waveform generation independent position in plant cells

(integrated in the chromosome, chloroplasts, mitochondria, or

maintained in a non-integrated form), and methods for the determination of the

it.



3. information on the expression of the insert:



a) information on the developmental of the Insert

expressed during the plant's life cycle and methods used for its characterisation

this.



b) parts of the plant where the insert is expressed (for example.

roots, stem, pollen).



4. information on how the genetically modified plant differs

from the recipient in the case of



a) mode (s) and/or rate of reproduction;



b) spread, and



c) survivability.



5. genetic stability of the insert and GMHV's

phenotypic stability.



6. any changes to the GMHV's ability to transfer

genetic material to other organisms.



7. information on any toxic, allergenic or other

harmful effects on human health or the environment, which

arise as a result of the genetic modification.



8. details of security with regard to the GMHV animal health, in the

case a GMHV is intended to be used in animal feedstuffs. The data

shall relate in particular to any toxic, allergenic or other

harmful effects arising from the genetic

modification.



9. Process for interaction between the genetically modified

plant and target organisms (if applicable).



10. Potential changes in GMHV's interaction with non-

target organisms resulting from the genetic modification.



11. Potential interactions with the abiotic environment.



12. Description of methods for detection and identification of

the genetically modified plant.



13. information about previous releases of the genetically

modified plant, if applicable.



E. information relating to the site of release (only for

applications made pursuant to Chapter 2. 3 or 6 of regulation

(2002:1086) concerning releases of genetically modified organisms in

environment)



1. location of the release site (s) and

size.



2. Description of the release site ecosystem, including

climate, flora and fauna.



3. The presence of sexually compatible wild relatives or

cultivated plant species.



4. Proximity to officially recognised biotopes or protected

areas that may be affected.



F. information relating to the release (only for requests that are made

According to Chapter 2. 3 or section 6 of the Ordinance (2002:1086) if

release of GMOs into the environment)



1. Purpose of the release.



2. Foreseen date and duration of the release.



3. the method by which the genetically modified plants will be released.



4. Method for preparing and managing the release site, prior to,

during and postrelease, including cultivation practices,

harvesting methods.



5. Approximate number of plants (or plants per square meter).



G. information on control, monitoring plans,

postrelease and waste management (only for

applications made pursuant to Chapter 2. 3 or 6 of regulation

(2002:1086) concerning releases of genetically modified organisms in

environment)



1. Any precautions taken:



a) Distance to sexually compatible plant species, both wild

relatives and crops.



b) measures to minimize or prevent the spread of any

reproductive organ of GMHV (e.g. pollen, seeds, tuber).



2. Description of methods for treatment of the site after

the release.



3. Description of treatment methods for the genetically

modified plant material including wastes, after

the release.



4. Description of monitoring plans and techniques.



5. Description of any emergency response plans.



6. Methods and procedures to protect the site.



Annex 3

Further information



Of this annex is provided a general description of the

additional information to be submitted in an application for

authorization for placing on the market and a

description of the information required for the marking, as well

of products consisting of or containing genetically

modified organisms to be placed on the market

as of genetically modified organisms which are exempted

from the provisions relating to the placing on the market in accordance

with Chapter 3. 1 § 1 and 2. The labelling requirements laid down in

4 Cape. 1 section should be met through appropriate

recommendations for, and restrictions on the use of

these genetically modified organisms (GMOs).



A. in addition to those mentioned in annexes 2, 2(a) and (B) shall

the following information is provided in the application for authorisation to

the placing on the market of products consisting of, or

genetically modified organisms (GMOs)



1. the proposed trade name, and the names of the

GMOs contained therein, and

any specific identification, name or code

used by the applicant to identify the genetic

modified organism. Since permission has been given to

an indication of any new trade names shall be submitted to

the competent authority.



2. Name and full address of the person

established in the European Union and responsible for

the placing on the market, whether it be the manufacturer, the

the importer or the Distributor.



3. Name and full address of the person (s)

that leaves the control samples.



4. Description of the product, and the genetically

modified organism constituting or incorporated in a product,

is intended to be used. Differences in use or

the management of the GMO

compared to similar non-genetically

modified should be highlighted.



5. Description of the geographical area

and types of environment where the product is intended

for use within the Union, including, if possible,

an estimate of the scope of use in each area.



6. Intended categories of users such as. industry, agriculture

and other professionals, consumers in General.



7. Information relating to the genetic modification. The data

should, where appropriate, contain the following information:

the deposit of samples of the genetically modified

the organism or its genetic material, with the competent

authority and details of nucleotide sequences and

other types of information necessary to identify a

product containing genetically modified organisms

and its results. With the latter data referred to

for example, a method to detect and identify the

product containing genetically modified organisms,

including information on experiments that show method

Special properties. Confidential information, which does not

can be introduced in the public part of the register, should

be identified.



This information shall be provided to make it possible to

incorporate modifications of organisms in one or more

registry. The registry is intended to facilitate

control and monitoring of products after they have

placed on the market, and will be used to track

and identify specific products containing

genetically modified organisms (GMOs).



8. Proposed labelling, on a label or in an

accompanying documents. This should include, at least in

condensed form, a commercial name of the product, a

explanation that "this product contains genetically

modified organisms ", the genetically modified

name of organism (s) and the information referred to in paragraph 2.

The label should indicate how information can be obtained in the

public part of the register.



B. in addition to those mentioned in paragraph (A) shall, in accordance with

3 Cape. section 4, the following information shall be provided in the application for

State when it is relevant



1. Measures to take in case of unintended release or

abuse.



2. Specific instructions or recommendations for

storage and handling.



3. specific instructions to the applicant that he should

implementation of monitoring and reporting. If the

required, such instructions also address

the competent supervisory authority, so that it can gain the necessary

information on potential adverse effects. These

instructions should be in accordance with annex IV, part C.



4. proposed restrictions on the use of the

genetically modified organism, such as information on

where the product may be used and for what purpose.




5. Proposed packaging.



6. Estimated production in and/or imports to the community.



7. Proposed additional labelling. This may include,

at least in condensed form, the information referred to in

points A4, A5, B1, B2, B3 and B4.

Regulation (2010:1193).



Annex 4



Monitoring plan



This annex describes the objectives to be achieved and the

General principles to be followed to design the

monitoring plan referred to in Chapter 3. 4, 17 and 31-32 §§

Ordinance (2002:1086) concerning releases of genetically modified

organisms in the environment.



For the purposes of this annex, taking into account Council

decision 2002/811/EC of 3 October 2002 on the indicative

comments to supplement annex VII to

European Parliament and Council Directive 2001/18/EC on the deliberate

release of GMOs into the environment and the

repeal of Council Directive 90/220/EEC.



A. Objectives



The objective of a monitoring plan is to



-confirm that any assumptions regarding the occurrence of risk assessment

and impact of potential adverse effects of the genetically

modified organism or its use is correct, and



-identify the occurrence of adverse effects on

human health or the environment which may arise from the genetic

modified organism or its use, and which are not

anticipated in the risk assessment.



B. General principles



In accordance with the provisions of Chapter 3. 4, 17 and 31-32 §§

Ordinance (2002:1086) concerning releases of genetically modified

organisms in the environment, monitoring take place after the

permission has been granted for the placing on the market of a

genetically modified organism.



The interpretation of the data collected by monitoring should

be made in the light of other existing environmental conditions and

other activities. When changes in the environment are observed,

further assessment should be considered to establish whether they are a

consequence of the GMO or its use

of it, since such changes may be the result of other

environmental factors other than the placing of the genetically modified

the organism on the market.



Experiences and the data collected by monitoring

experimental release of GMOs

can be helpful in the formulation of the monitoring system

to be applied for the placing on the market and which

required to get market products consisting of, or

contains genetically modified organisms.



C. design of the monitoring plan



The monitoring plan should be drawn up in accordance with the following.



1. The plan should be as detailed as each case requires

with regard to the risk assessment.



2. The plan should be considered genetically modified organism

characteristics, the intended use and scope properties

and the extent of relevant environmental conditions where the

GMO is expected to be released.



3. The plan should incorporate general surveillance for

unforeseen adverse effects and, if necessary, whereas case-specific

monitoring focusing on adverse effects

identified in the risk assessment.



3.1. Whereas case-specific monitoring should be carried out for a sufficient

long time to detect immediate and direct as well as, in

where appropriate, delayed or indirect effects which have

identified in the risk assessment.



3.2. Whereas surveillance could, if appropriate, make use of

already established routine surveillance practices such as

monitoring of agricultural plant species, plant health, veterinary

products or drugs. An explanation should be given of how

relevant information collected through established

routine surveillance practices will be made available to the

the holder of the authorization.



4. The plan should facilitate the systematic observation of

the release of a genetically modified organism within the

receiving environment and the interpretation of these observations with

regard to human health and the environment.



5. The plan should be established who, licence holders or growers,

will carry out the various tasks required by

the monitoring plan and who is responsible for ensuring that the

the monitoring plan shall be drawn up and implemented in an appropriate manner,

and make sure that there are ways to inform

holder and the competent authority of any

observed adverse effects on human health or the environment

(times and intervals for reports on the results of

the monitoring shall be indicated).



6. In the plan should be taken into account the mechanisms to identify and

confirming any observed adverse effects on human

health or the environment. It should make it possible for

the holder of the authorization or, where applicable, the competent

authority to take the necessary measures to

protect human health and the environment.

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