Definitions
Article 1 terms and expressions used in this regulation has the same
meaning as in chapter 13. the environmental code. Regulation (2011:32).
paragraph 2 of this regulation,
"micro-organism" shall mean any microbiological entity, cellular or non-
cellular, capable of replication or of transferring genetic material;
including viruses, viroids and cell cultures of plants and animals,
genetically modified micro-organism: a micro-organism in which the
the genetic material has been altered in a way that does not occur
naturally by mating and/or natural recombination;
protective measure: a containment measures or precautions
otherwise, taken to prevent, hinder or discourage
activities involve harm to human health or the environment,
supervisory authority: an authority referred to in Chapter 2. 4, 12, 13
or section 18 of the environmental protection Decree (2011:13) has responsibility for
supervision in the case of contained use,
F-activities: the contained use of genetically modified
microorganisms with negligible or no risk of harm to
human health or the environment,
L-activities: the contained use of genetically modified
microorganisms with a low risk of harm to human health
or the environment,
R-activities: the contained use of genetically modified
microorganisms with moderate or high risk of damage to the
human health or the environment,
new use: a the contained use of genetically modified
organisms in an already registered and is compared to the
notified operation on a non-negligible way differ in
the case of the genetically modified organisms used
or in respect of the methods for the manufacture or
the use of the organisms,
accident: any incident involving a significant and unintended
the release of genetically modified organisms in contained
use and that may pose an immediate or delayed danger
to human health or the environment. Regulation (2011:32).
2 a of for the purposes of this regulation,
Directive 90/220/EEC: Council Directive 90/220/EEC of 23 april
1990 on the deliberate release into the environment of genetically modified
organisms in the environment, as last amended by Commission directive
97/35/EC,
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
European Parliament and Council Directive 2008/27/EC, and
Directive 2009/41/EC: European Parliament and Council directive
2009/41/EC of 6 May 2009 on the contained use of
genetically modified micro-organisms (recast).
Regulation (2011:125).
Exemptions for certain activities
the provisions of paragraph 3 of 8-11 and 13-34 paragraphs shall not apply in
question on the contained use of
1. organisms that are produced or obtained through
mutagenesis,
2. plants that are produced or obtained by cell fusion
(including protoplast fusion) of plant cells where the plant
can also be produced by traditional breeding methods,
3. micro-organisms that are produced or obtained through
cell fusion (including protoplast fusion) of prokaryotic species that
Exchange genetic material by known physiological processes,
If it is unlikely that the micro-organism is harmful to
human health or the environment,
4. micro-organisms that are produced or obtained through
cell fusion (including protoplast fusion) of cells of any eukaryotic
species, including production of hybridomas and mergers
of plant cells,
5. micro-organisms that are produced or obtained through
self cloning of cells of the same species or into cells of
phylogenetically closely related species which can exchange genetic
material by natural physiological processes, if it is
unlikely that the micro-organism is harmful to human health
or the environment.
Self-cloning consisting in the removal of nucleic acid sequencing
a cell in an organism and, possibly, to all or part of the
nucleic acid or a synthetic equivalent since reinstatement
with or without prior enzymic or mechanical steps.
Self-cloning referred to in the first subparagraph 5 shall include
the use of such for a long time proven recombinant
vectors that have been shown to lead to the use of the
individual organisms are safe.
The opt-out in the first subparagraph shall not apply if the
the operations involve the use of recombinant
-nucleic acid molecules or in addition to such
contained uses referred to in the first paragraph also covers
the use of genetically modified organisms obtained
or obtained otherwise than as mentioned in the first
paragraph 1-5.
section 4 provisions of Chapter 13. section 8 environmental code and 7-11 and 13-34 of this Regulation shall not apply to contained
use only such genetically modified
micro-organisms that are safe for human health and the environment
According to Directive 2009/41/EC.
The work environment authority shall draw up a list of the types of
genetically modified microorganisms referred to in the first
paragraph. The list should correspond to the list in part C of the
Annex II to Directive 2009/41/EC. Regulation (2011:125).
§ 5 the provisions of paragraphs 7 to 34 do not apply to the storage, culture,
transport, destruction, disposal or use of the
GMOs which have been placed on the
market in accordance with
1. Directive 90/220/EEC or Directive 2001/18/EC,
2. other EU legislation that provides for a
specific environmental risk assessment similar to that laid down in
Directive 2001/18/EC,
3. Ordinance (1994:901) on genetically modified organisms
or Ordinance (2002:1086) on release of genetically
modified organisms in the environment.
The exemption provisions in the first subparagraph shall not apply if the
the contained use differs from the permit conditions
placing the organisms on the market. Regulation (2011:125).
the provisions of paragraph 6 of the 8-11 and 13-29 sections do not apply to the transport of
genetically modified organisms by road, rail or
inland waterway, sea or air.
Risk assessment
section 7 of the operator or intends to operate with
the contained use of genetically modified organisms shall
do the investigation for the assessment of risks referred to in 13
Cape. section 8 of the environmental code.
The supervisory authority may, within its regulatory area Info
the methods of investigation and what it should include.
section 8 a business with the contained use of genetically
modified micro-organisms shall be classified as an F-
activities, L-R-business activities. The risk assessment
referred to in section 7 shall be the basis for classification.
The work environment authority may, within its regulatory area Info
the details about the meaning of F, L-
activity and R-activities and rating. Before
The work environment authority will notify such provisions, the
consult the gene technology Committee, and Naturvårdsverket.
Regulation (2000:968).
Protection measures
§ 9 The carrying on or intending to carry on business with
the contained use of genetically modified organisms
shall, in the context of the risk assessment referred to in section 7, judge
the protective measures are needed. In Chapter 2. section 3 of the environmental code, see
a provision on the obligation to perform such safeguards.
The supervisory authority may, within its regulatory area Info
regulations on how the need for protective measures shall
be identified and assessed.
section 10 of the contained use of genetically modified
organisms, physical barriers, or a combination of physical
and other barriers used to limit the organism
contact with the general population and the environment.
section 11 of the supervisory authority may, within its regulatory area Info
regulations about the doing business with enclosed
the use of genetically modified organisms shall
maintain a certain level of protection for human health and the
the environment (protection level). Such rules may mean that a
particular circumstance in risk assessment or to the need for a
some protective action is decisive for the choice of the level of protection of
all or part of the business.
section 12 of the supervisory authority may, within its regulatory area Info
the additional regulations on protective measures needed for
the contained use of genetically modified organisms.
The regulatory authority shall consult the Authority for
civil contingencies Agency, the environmental protection agency and
The gene technology Committee before it announces regulations on transport
of genetically modified organisms (GMOs) or that otherwise relate to
measures for the protection of the environment or to people outside the
establishments where activities with genetically modified
organisms are conducted. Regulation (2008:1032).
Update of estimates
paragraph 13 of the assessments referred to in paragraphs 7 and 9 shall be reviewed and
updated on a regular basis.
Such a review shall be made immediately if
1. classification under section 8 is no longer real,
2. the selected level of protection within the meaning of section 10 is no longer sufficient,
3. the safeguard measures are no longer sufficient,
or
4. in the light of new scientific or technical knowledge
There is reason to suspect that the assessment is no longer
real.
Documentation
section 14 of the supervisory authority may, within its regulatory area Info
provisions on the obligation to document the assessments
made under sections 7 and 9, to keep the documentation available
and submitting it to the regulatory authority.
Notification and authorisation obligation, etc.
15 § a business with the contained use of genetically
modified organisms may be carried out only if the notification has
completed or permission has been granted in accordance with the provisions
in §§ 16-29.
section 16 of the notification shall be made to the supervisory authority which is
responsible supervisory developments. The Authority also
questions about permits.
section 17 A notification or application for authorisation shall be
include a summary of such risk assessment referred to
in section 7 and an explanation of the need for protective measures pursuant to
the assessment referred to in section 9.
The supervisory authority may, within its regulatory area Info
additional regulations on what a notification or application shall
contain.
section 18 When the regulator has received a notification or
the application, it shall examine whether
1. the requirements under section 17 are met and if the information
submitted may be accepted as correct and complete,
2. risk assessment can be considered real,
3. the proposed protection measures are adequate.
The supervisory authority may submit to the notifier or the applicant to
provide the additional information needed
trial.
19 § When the regulatory authority has received the information necessary
to the data and assessments shall be accepted as
complete and correct, the authority shall inform the
the notifier or applicant that a complete notification or
the application has been received.
section 20 on the content of a complaint raises, or if
the supervisory authority is aware of circumstances that may have
substantial importance to the risk associated with the activity,
authority may decide
1. the specific conditions shall apply for the business,
2. the activity must not commence or be operated without
special permit,
3. the activity may be carried out only for a limited time,
or
4. that the business may no longer be operated.
section 21 Of the business changed in a way that can have a significant
importance of risk associated with the activity, the operator
activities as soon as possible inform the supervisory authority.
The notification obligation also applies if the operator
business becomes aware of circumstances that may have such
importance.
section 22 if the information previously filed in a declaration or
the application is no longer accurate or has become outdated,
the program operates to ensure that the previously
made notification or application changed or updated in
the relevant parts. This obligation also applies if the activity
has been discontinued.
The supervisory authority may, within its regulatory area Info
details relating to the revision and update.
Specific provisions relating to the activities of microorganisms
section 23 where the supervisory authority does not decide otherwise, gets an F
activities or L-activities commence at the earliest 45 days after the
the full report has been made under the provisions
in paragraphs 16 to 19.
section 24 without a special registration needs to be done, get a new
use in a business carried on in a place or in a
facility that is already covered by a complete notification pursuant to
16-19 sections. The provisions of §§ 21 and 22 on the obligation to
inform the supervisory authority as well as to modify and update the
previous notification shall, however, apply.
section 25 A new use of an L-activity must not be operated without
that the use has been notified pursuant to the provisions of §§ 16-19.
Where the supervisory authority does not decide otherwise, the new
the use is begun immediately after a complete
notification has been made, if it intends to engage in the use of a
location or in a facility that is already covered by a
full registration, or a permit for a L-activities
or R-activity and the conditions attached to the
the business has been met.
paragraph 26 of A R-activity or a new use of an R-activities
must not be carried out without the authorisation of the supervisory authority.
If the new use means a use according to section 25 of the other
the paragraph that is conducted within the framework of a State for a R-
activities, it is sufficient that a notification is made in accordance with section 25 of the
the first paragraph. Regulation (2011:125).
section 27 Of the supervisory authority decides otherwise on the basis of section 20,
It shall notify its State
1. within 90 days after the date of a complete application
received,
2. within 45 days after the date of a complete application
received, if the application relates to a new use, provided that
be conducted in a location or in a facility that is already covered
a permit for a R-activity and the conditions
the activities have been met.
Specific provisions on activities with other organisms than
micro-organisms
section 28 A second plant for the contained use of genetically
modified organisms other than micro-organisms must not be used for
such activities without the authorisation of the supervisory authority.
Permission may be granted only if the plant is acceptable from
health and environmental protection point of view.
The authority shall notify its decision in
licensing question within 90 days of a complete
application has been made.
29 § a business with contained use of other genetically
modified organisms other than micro-organisms may be carried out only
If the business has been notified pursuant to the provisions of §§ 16-19.
If the supervisory authority within its regulatory area not
provides otherwise, the notification obligation applies also to each
new use.
Where the supervisory authority does not decide otherwise, the activities
or the new use commences no earlier than 45 days after the
a full report has been made.
The regulatory authority may, in the particular case, decide on the
exemption from the notification requirement, the
construction and circumstances otherwise make to the protection of
human health and the environment can be considered to be sufficiently
met.
Contingency plans
section 30 of the supervisory authority may, within its regulatory area Info
provisions on the obligation of the doing business with
the contained use of genetically modified organisms to
draw up a contingency plan for the business.
section 31 of the supervisory authority shall ensure that emergency plans
established for operations with the contained use of
genetically modified micro-organisms, if
containment measures are not working, may result in immediate
or delayed serious danger to people outside the
establishments where activities are carried on or for the environment.
A contingency plan should mean that the operator
the business provides information on planned security measures.
The information shall be submitted to the relevant authorities and other
may be affected by an accident. It should be provided as appropriate and
without the recipients need to request that it be submitted.
The information should be kept updated and available for
members of the public. Regulation (in 2008:52).
32 § At handling cases on contingency plans and
regulations on such plans, regulators
consult the Swedish civil contingencies Agency.
Regulatory authorities shall inform the authority of
civil contingencies Agency on the contingency plans
be established. Regulation (2008:1032).
Accidents, etc.
33 of the Act (2003:778) the accident prevention provisions
If obligations at hazardous activities etc.
The supervisory authority may, within its regulatory area Info
further provisions on the obligation of the operator of a
activities involving the contained use of genetically modified
organisms that in the event of an accident, incident or illness
that can be associated with the use of the organisms in the correct
the relevant authorities. In addition, to provide for
obligation for students engaged in operations to leave the
information needed to take the necessary protection measures should
able to be taken. Regulation (2003:799).
34 section about it in a business with the use of genetically
modified organisms occurs, an accident should
the supervisory authority
1. ensure that the necessary protective measures are taken,
2. immediately warn the Member States of the European Union
can be affected by the accident,
3. If possible, collect the information necessary for a
full analysis of the accident, and
4. issue the recommendations needed to prevent
similar accidents in the future and limit such accidents
effects.
If there is an immediate serious danger to the environment or for
people outside the premises where the activities are carried out,
the supervisory authority shall immediately notify the municipal
the Organization of emergency services and the Agency for
public safety and emergency preparedness. Regulation (2008:1032).
35 § Working Environment Authority to respond to the consultation and
the notifications referred to in article 15 of Directive 2009/41/EC.
Regulation (2011:125).
Reporting
36 § Working Environment Authority supposed to fulfill the reporting to
The European Commission referred to in article 17 of Directive
2009/41/EC. Regulation (2011:125).
Transboundary movement of genetically modified
organisms
36 a of the environmental protection agency to coordinate the national work
with Sweden's participation in the international
the information procedure pursuant to European Parliament and Council
Regulation (EC) no 1946/2003 of 15 July 2003 on
transboundary movement of genetically modified
organisms.
The supervisory authorities shall communicate to the
The environmental protection agency in accordance with article 15(1) of that regulation.
Regulatory authorities shall consult with the environmental protection agency on how
data shall be provided. Regulation (2006:1503).
Appeal and penalty and forfeiture
section 37 of chapter 19. § 1 and 29. the environmental code includes provisions
on appeal, and on penalties and forfeiture.
Entry into force and transitional provisions
2000:271
1. This Regulation shall enter into force on 5 June 2000. In the case of
activities with genetically modified organisms other than
micro-organisms applied, however, the provisions of 3-7, 9, 11-22,
28-30 and 32-34 §§ until 1 May 2001.
2. The following apply to a business with GM
microorganisms that were started before 5 June 2000 and
is registered or subject to authorisation in accordance with regulation
(1994:901) on genetically modified organisms. Activities
may continue to be conducted as if the notification were completed or
the permit has been issued under this regulation. In addition to what
resulting from the 20 or 21 of this regulation, the
operates to ensure that information about changes or
updates under section 22 shall be submitted to the supervisory authority
by 30 september 2000. The regulatory authority may, in the
each case shall decide on a later date.
3. The following apply to a business with GM
microorganisms that were started before 5 June 2000 and
is the registration or permit under this regulation
but that has not been reported or subject to authorisation in accordance with
Ordinance (1994:901) on genetically modified organisms.
The operator business shall, not later than 5 June 2000
inform the supervisory authority of the activities are carried out and
provide the information as requested by the supervisory authority to
tentatively assess whether the business is a F-business, L-
activities or R-business. If it is likely that
the business is a business, it may continue to be carried out
Notwithstanding that the notification is not completed in accordance with §§ 16-19
This regulation. In other cases, the supervisory authority
decide on the conditions under which operations can be carried out despite
that notification is not completed or permission granted
According to this regulation. Operations can be carried out pending
on the supervisory authority's decision. The provisions of §§ 20 and 22 shall
apply as if the notice were a completion notification. If
the supervisory authority does not decide otherwise, the activity is not
be conducted with the aid of this transitional provision after 30
September 2000. An operation must not be carried out under cover
of this transitional provision, if the operations before the June 5
2000 has been carried out in violation of the provisions on permit requirements
in the Ordinance (1994:901) on genetically modified organisms.
4. The following apply to an activity with other genetically
modified organisms other than micro-organisms if the business has
started before 1 May 2001. The business may continue to
be conducted as if the notification is completed or permission has
granted under this regulation until
the supervisory authority decides otherwise. This applies during
condition that the notification under section 29 shall be submitted to
the supervisory authority by 1 June 2001, and that the application for
authorization under section 28 shall be submitted to the regulatory authority no later
on 1 september 2001. The regulatory authority may in the individual
the case decide on a later date. Regulation (2001:19).
