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.