Introductory provisions
section 1 of this regulation is notified pursuant
— Chapter 14. section 8 of the environmental code in case of 5, 7-8, 20-21, 23, 29
and sections 37,
— Chapter 14. section 11 of the environmental code in terms of 10, 11 and 25 to 28 § §,
— Chapter 14. section 19 of the environmental code in terms of §§ 12 and 13, section 24
the second and third paragraphs and section 36, and
– Chapter 8. 7 and 11 of the Constitution in the case of other
provisions. Regulation (2014:428).
paragraph 2 of this regulation,
integrated control: a rational use of a
combination of biological, biotechnological, physical,
chemical or cultivation or breeding related
measures which limit the use of chemical
plant protection products to what is strictly necessary to
keep the stock of the harmful organisms at such a low level
to economically unacceptable damage or loss not
caused,
' harmful organisms ': pests of plants or plant products
belonging to the animal or plant kingdoms, or which are made up of
virus, bacteria or Mycoplasma or other pathogens,
active substances: substances or micro-organisms, including
viruses, having general or specific action against harmful
organisms or on plants, parts of plants or plant products,
plants: live plants and live parts of plants, including
fresh fruits and seeds,
plant products: products of plants that are unprocessed
or which have only undergone a simple preparation, such as
milling, drying or pressing,
plant protection products: chemical products, biotechnical organisms
as well as chemical or biological pesticides according to
the definitions in chapter 14. the environmental code which, in the form in which they
delivered to the user, intended to
– protect plants or plant products against harmful
organisms or prevent impact from such
organisms,
– influence the life processes of plants, other than as
nutrition,
to preserve plant products, in so far as the chemical product;
the biotech organism or the pesticide does not
covered by specific EU rules relating to preservatives,
– destroy undesirable plants, or
– destroy parts of plants or inhibit or prevent undesired
growth of plants, and
plant protection product directive: Council Directive 91/414/EEC of
15 July 1991 concerning the placing of plant protection products on the
the market, as last amended by Commission directive
2010/58/EU.
In addition, the terms and expressions in this regulation the same
meaning as in chapter 14. the environmental code. Regulation (2010:1196).
Scope of application
2 a of this Regulation shall apply to plant protection products
contains nematodes, insects or Arachnids and not
subject to approval in accordance with
1. European Parliament and Council Regulation (EC) No 1107/2009
of 21 October 2009 concerning the placing of plant protection products on the
the market and repealing Council Directives 79/117/EEC, in
the wording according to Council Regulation (EC) no 518/2013, or
2. European Parliament and Council Regulation (EC) No 528/2012
of 22 may 2012 if the making available on the market and
the use of biocidal products, in wording as
European Parliament and Council Regulation (EC) No 334/2014.
Regulation (2014:428).
2 b repealed by Regulation (2014:428).
2 (c) repealed by Regulation (2014:428).
2 (d) repealed by Regulation (2014:428).
Rules on exemptions
3 repealed by Regulation (2014:428).
Approval
section 4 of the Swedish Chemicals Agency examines issues concerning the approval according to
Chapter 14. section 10 of the environmental code of plant protection products covered by the
This regulation. If necessary, the authority shall hear the State's
agricultural works and NFA. Regulation (2014:428).
paragraph 5 of the Chemicals Inspectorate must notify such provisions if
exemption from the requirement to obtain the approval in chapter 14. section 4 of the environmental code
that there are special reasons for or in the case
provide an exemption from the requirement for approval. If a waiver is granted, the
It blends well with the conditions that are needed with regard to the protection
to human health and the environment. Regulation (2014:428).
repealed by regulation 6 (2014:428).
section 7 does not require a new authorisation to another
name place a pesticides on the market that in everything
essentially is the same as a medium that is approved according to
This regulation, on the same vehicle
1. contains the same active substance in the same content,
2. is produced by the same method as the authorised agent,
3. have the same functions and features as the authorised agent,
4. meet the same security requirements as the authorised agent,
5. have a title that may not lead to confusion with the
approved agent or would otherwise be contrary to section 11, and
6. is notified to the Swedish Chemicals Agency and the notification contains
the documents necessary to demonstrate that the requirements of 1-5 is
met.
section 8 even though an approval under this regulation is repealed
Swedish Chemicals Agency may decide that a medium that is notified
under section 7, may continue to be placed on the market under
the remainder of the term of validity laid down in the decision on the
approval, if
1. the annulled the approval relates to a vehicle which is still
approved in another country of the European Union or the European
economic area,
2. the suspension does not refer to the product's efficacy or other
characteristics which are important from a health or
point of view of environmental protection, and
3. the conditions concerning the active substance for a
approval in the European Union or the European economic
area does not mean a geographical restriction
exclude the use of the vehicle in Sweden.
Conditions for approval
§ 9 an application for authorisation or for the amendment of an
approval shall be made by or on behalf of the
responsible or will be responsible for ensuring that the product was first released
on the market in Sweden. The applicant shall have a fixed
Office in a country within the European Union or the European
economic area.
section 10 of the Swedish Chemicals Agency must notify the
the conditions for the authorisation should apply according to chapter 14.
section 10 of the environmental code in terms of the composition of the plant protection product,
mode of action and properties in General and the need on the basis of
control purposes. Regulation (2008:259).
section 11 of a plant protection product shall not be authorised if its title
can be considered as misleading as to the product's composition,
mode of action or characteristics in General, or may lead to
confusion with a different pesticides.
Requirements for documentation, etc.
section 12 of the application for approval shall include a documentation
about the product and its active substance.
If the active substance is included in annex 1 to
plant protection product directive and the applicant demonstrates that the applicant has
access to the complete dossier on the subject,
need application with regard to the active substance only contain
the documentation necessary to
1. identify the active substance, and
2. Note that the active substance in terms of purity
and the nature of impurities is not significantly different
from the Assembly that is specified in the documentation
that was the basis for the inclusion in annex I to
PPP directive.
paragraph 13 of the Swedish Chemicals Agency must notify the regulations on
documentation and samples required in respect of
plant protection product directive or as otherwise needed to
the inspection shall be able to carry out its review.
Use of the documentation submitted by applicants other
14 repealed by Regulation (2014:428).
15 repealed by Regulation (2014:428).
16 repealed by Regulation (2014:428).
section 17 was repealed by Regulation (2014:428).
section 18 is repealed by Regulation (2014:428).
§ 19 is repealed by Regulation (2014:428).
Conditions of an authorisation shall be accompanied by
section 20 When a plant protection product is approved, its health and
environmental hazards be assessed by reference to the
area of use. On the basis of such an assessment must
vehicle attributable to any of the following classes:
-class 1: funds may be used only for professional use
by special permit,
-class 2: funds may be used only for professional use
of satisfying specific skill requirements, if not
The Swedish Chemicals Agency decides otherwise in connection with the
authorisation, or
-class 3: funds that may be used by everyone.
section 21 in order to ensure that such rules referred to in
section 10 is followed, the Chemicals Inspectorate after consultation with other
the authorities concerned may decide that approval shall be subject
with special conditions in addition to the provisions of the applicable
regulations on management, classification, packaging,
labelling and other product information. The specific terms and conditions
shall be indicated in the authorisation. Regulation (2008:259).
The period of validity
section 22 of an approval may be given only for a certain time. Out of 14
Cape. section 10 of the environmental code, it appears that the time may be determined to
a maximum of 10 years.
If an active substance in the vehicle are listed in annex 1 to
plant protection product directive, approval is granted only for the time
the substance, as specified in the list, should be included
in the list. Regulation (2008:259).
section 23 of the period of validity of an authorisation may be extended if the
conditions for approval in section 10 is still
met. The Swedish Chemicals Agency may decide that approval
is extended for the time required for this test.
Obligation to inform about new information
section 24 Such notifications of adverse effects referred to in
Chapter 14. section 18 of the Swedish environmental code shall be made to the Swedish Chemicals Agency.
The program has been approved or a plant protection product in accordance with section 27
has received an extension of the product range of applications approved,
shall immediately inform the Swedish Chemicals Agency if
changing circumstances relevant to the approval.
The Swedish Chemicals Agency must notify the
the notification obligation. Regulation (2008:259).
Review, amendment and revocation of authorisation
section 25 approval may be reviewed if there are tasks that
suggests that any condition referred to in section 10 is not
met.
Upon reconsideration, the Swedish chemicals agency require the information
needed for the review. The inspection may decide to
the approval is extended for the time needed for the review
and for the provision of the information required.
section 26 an approval may be amended in respect of conditions for
use, if a change is justified in the light of new
Scientific and technical knowledge.
An amendment may also be made if the applicant for approval
request and state the reasons for it.
An amendment may be granted only if the conditions referred to
in section 10 are still fulfilled.
section 27 of the public or scientific bodies in the field of agriculture,
agricultural organisations and professional users may apply to
use of a plant protection product that is already authorised
should be broadened to cover purposes other than those covered
of the authorisation.
The application may be extended if the proposed use
is on a smaller scale and if necessary to meet the
public interests.
The Swedish Chemicals Agency may provide the additional regulations
If the conditions for enlargement is needed because of
Article 9(1) of the PPP directive.
section 28 an approval shall be revoked if the conditions
referred to in section 10 are no longer fulfilled, or if incorrect or
misleading information was submitted regarding the circumstances
on the basis of which the authorisation.
An authorisation may also be cancelled if the applicant for
the approval request and state the reasons for it.
If an authorisation is revoked, the Swedish Chemicals Agency
immediately notify the
1. a person who has a plant protection product authorised
2. under section 7 have signed a similar medium or
According to § 55 has received such funds registered, and
3. under section 27 has been an expansion of the product
use approved.
section 29 in connection with that approval is revoked,
The Swedish Chemicals Agency decide that existing stocks of the product
for disposal, storage, placing on the market and use of
during a certain period of time. The length shall be determined taking into account the
what caused the suspension.
The decision may not mean that the placing on the market
or used in contravention of other provisions applicable
at the vehicle.
The Swedish Chemicals Agency must notify the
the application of the first subparagraph.
section 30 is repealed by Regulation (2014:428).
section 31 Has been repealed by Regulation (2014:428).
repealed by regulation 32 (2014:428).
repealed by regulation 33 (2014:428).
repealed by regulation 34 (2014:428).
repealed by regulation 35 (2014:428).
Classification, packaging and labelling
36 § the Swedish Chemicals Agency must notify the regulations on
classification, packaging and labelling is needed with regard
to the protection of human health or the environment, or as needed
on the occasion of the PPP directive.
37 § plant protection products and active substances intended for use
in plant protection products may not be placed on the market unless they
classified, packaged and labelled in accordance with the regulations
referred to in section 36.
Manufacture, storage and transportation in some cases
38 section To a plant protection product is not authorized under the
the provisions of Chapter 14. Environment Act and this regulation,
not be added to the base to prevent the medium is manufactured,
stored or transported, if the product is authorised in another
country within the European economic area and is intended
to be used in such a country.
Despite the first paragraph, the Swedish Chemicals Agency, notify
rules about what the program produces, stores or
transporting pesticides must do to
the supervisory authority must be able to verify that the product is not
placed on the market in breach of the provisions of
approval. Regulation (2008:259).
Information on the transfer
38 a of The professional transferring pesticides to
someone who does not use the medium professional shall inform
the user of the
1. to use can result in a risk of injury or
inconvenience to human health and the environment,
2. the dangers of handling can mean and how should
stored, disseminated or otherwise handled,
3. how the residue after use should be taken care of, and
4. possible options that involve less risk.
Regulation (2012:236).
38 b of the Swedish Chemicals Agency may announce detailed rules
If the information referred to in section 38. Regulation (2012:236).
Use
39 section in article 55 of Regulation (EC) No 1107/2009 there is a
provision for the use of plant protection products shall comply with the
General principles of integrated pest management as
1. does a careful consideration of all available
plant protection techniques and subsequent integration of appropriate
measures that discourage the development of populations of
harmful organisms,
2. keep the use of plant protection products and other forms of
intervention at levels that are economically and ecologically
justifiable and that reduces or minimizes the risks of
human health and the environment, and
3. Emphasizes the cultivation of a healthy crop with the least possible
interventions in agricultural ecosystems and encourages natural
mechanisms for the control of pests and weeds.
Regulation (2014:143).
39 a of the State's agricultural work may provide for the
General principles of integrated pest management in accordance with
Annex III to European Parliament and Council directive
2009/128/EC of 21 October 2009 establishing a framework
for Community action to achieve a sustainable use
of pesticides, in the original wording.
Before the Agriculture Department will notify such provisions to the work
hear the Swedish Chemicals Inspectorate and, if
forest land is concerned, the Swedish forest Agency. Regulation (2014:143).
Distribution of plant protection products
40 of a plant protection product which is especially harmful to
pollinating insects are not to be used for treating plants
during the time of day when the bumble bees and bees are active on
plant site.
If there are special reasons, the State's agricultural work Info
regulations on exemptions, or in each case decide on the
exemption from the prohibition laid down in the first subparagraph.
The State's agricultural work may provide for the obligation
to take notes at the professional distribution of such
plant protection products as referred to in the first paragraph.
40 a of The spreading plant protection products falling within class
1 or 2 under section 20 should make note of each dissemination action and
specify the safety distance that have been held at which
takes place outdoors, what other precautions for the protection
against environmental influences that have been taken by the proliferation, as well as in
What is the purpose of the plant protection product has been used.
Regulation (2014:143).
40 b of the State's agricultural work may provide for
Note the obligation in paragraph 40. Regulation (2014:143).
41 section environmental protection agency may announce further provisions concerning
the spread of a plant protection product, including the requirements for a permit
and notification for specific areas.
42 § the Swedish Chemicals Agency, in each case provide waivers
from the prohibition in chapter 14. paragraph 7 of the first paragraph, the environmental code, if the
There are serious reasons, and from the prohibition in chapter 14. section 7 other
subparagraph, the environmental code, if required for scientific examination.
Before a decision to grant a derogation from the prohibition provided for in chapter 14. paragraph 7 of the first
subparagraph, the environmental code, Swedish Chemicals Agency shall consult with
The environmental protection agency, the State's agriculture and Forestry Board.
Regulation (2008:259).
43 § National Board of forestry, in the particular case waive
prohibition in chapter 14. the second subparagraph of paragraph 7 the environmental code, if it is
account of forest location and nature, forest stock
composition, the impact on the living conditions of
plant and animal life, and other general interests cannot reasonably
going through clearing using mechanical means meet the requirement
If the regrowth of forest in section 6 of the Forestry Act (1979:429).
Regulation (2008:259).
section 43 (a) a waiver under section 42 or 43 to unite with the
conditions needed from health and environmental protection point of view. A
such an exemption may also be reconciled with the requirements of notification before
the plant protection product is used.
A derogation from the prohibition provided for in chapter 14. first subparagraph of paragraph 7
the environmental code should always be combined with the conditions necessary for
to comply with article 9 (2) of the European Parliament and Council directive
2009/128/EC of 21 October 2009 establishing a framework
for Community action to achieve a sustainable use
of pesticides. Regulation (2012:236).
Knowledge requirements, etc. in some cases
44 § A plant protection products falling within class 1 or 2
under section 20 may be used only by those who meet specific
knowledge requirements.
Regulations on specific knowledge requirements may be subject to requirements on
to the user of the plant protection product must have achieved a certain
age.
section 45 the authority according to § 47 hears questions about permits
may provide for the skills that are required and if
age limits for use. Before a rule is announced,
the authority shall consult the Swedish Chemicals Agency.
section 46 Of regulations referred to in section 45 include requirements to
users of plant protection products must have undergone some
education, the State's agricultural work provide for
to the County Board shall ensure that the training is conducted
and how the provincial government will implement it.
Permission for use
47 § A plant protection products falling within class 1 under section 20
may be used only with special permission. A State must
be for some time.
Issue of permits is tested
1. as regards activities which mainly relate
Agriculture, forestry or gardening by State
agricultural works;
2. as regards measures against vermin and pests according to 9
Cape. section 9 of the Environment Act of the public health agency, and
3. in the case of activities other than in 1 and 2 of
The Swedish work environment authority.
The State's agricultural work may provide for the
licensing issues as referred to in the second subparagraph 1 shall be reviewed by the
Agriculture Department instead will be reviewed by the County Administrative Board.
Regulation (2013:905).
48 § 47 the authority under § examines the issue of permits
may provide details relating to the conditions for such
State. Regulations shall refer to conditions that have
importance of compliance with the provisions of section 39 or of
such provisions referred to in paragraphs 41 and 45. Before a
Regulation will be announced, the Agency shall consult with the
The Swedish Chemicals Agency.
Temporary restrictions and prohibitions
49 § if there is reason to suspect that an approved
plant protection products or a means that the Swedish Chemicals Agency
is required to approve poses a risk to human health
or the environment, it may temporarily restrict or inspection
prohibit the use or sale of the vehicle. If
the inspection shall notify such a decision, the inspection
immediately inform the European Commission and the other
the Member States of the European Union.
Regulation (2010:1196).
Some products that have been treated with plant protection products
50 § cereals, potatoes or other seed that has been used with
plant protection products may only be used as the seed.
The State's agricultural work may provide for
1. that the seeds referred to in the first subparagraph may be stored
only in some kind of container, and
2. that the packaging material that has been used for the storage of seed
referred to in the first subparagraph may not be used for other purposes
or may only be used for some other purpose.
51 § conifer seedlings which have been treated with a
plant protection products in the form of a chemical pesticides that are not
approved pursuant to this Regulation may not be recorded to the
Sweden.
If there are special reasons, the Swedish Chemicals Agency in
particular case waive the prohibition referred to in the first subparagraph.
Supervision and fees
52 § provisions on supervision, see chapter 26. the environmental code and the
environmental protection Regulation (2011:13). Provisions on the
operational supervisory responsibilities associated with this regulation
see Chapter 2. 4, 20, 21 and 29 – 32 §§
environmental protection regulation.
Provisions on fees can be found in the Ordinance (1998:940) if
fees for the examination and supervision under the Environment Act.
Regulation (2011:42).
Appeal and penalty and forfeiture
53 of chapter 19. § 1 and 29. the environmental code includes provisions
on appeal, as well as penalties and forfeiture.
The exchange of information within the European Union, etc.
54 § in the case of messages, notifications and other
information to the European Commission and other
Member States of the European Union or the European
economic area, should the Swedish Chemicals Agency
carrying out the tasks that Sweden has, according to
plant protection product directive
1. transitional provisions,
2. measures to provide information on
applications and to make documentation available,
3. the provisions on Exchange of information on
decision in respect of acceptance, waiver and withdrawal
as well as lists of approved products,
4. measures to provide information on what
arrive in the examination of an application for authorisation,
5. measures to provide information on such
harmful effects referred to in section 24,
6. rules on derogations from the labelling requirements, and
7. provisions on the reporting of the results of the measures taken
supervisory measures. Regulation (2010:1196).
55 § the Swedish Chemicals Agency must keep a record of the name
notified under section 7.
Transitional provisions
2006:1010
1. This Regulation shall enter into force on 1 January 2006, when
Ordinance (1998:947) on pesticides shall cease to
apply.
2. Older rules still apply for decisions
granted prior to the entry into force.
2011:929
1. this Regulation shall enter into force on 1 August 2011.
2. Older provisions still apply to cases where
authorisation of plant protection products in the cases specified in article
80(5) of Regulation (EC) No 1107/2009.
2014:143
1. This Regulation shall enter into force on 17 april 2014.
2.40 a of the need to spread pesticides before
from 1 January 2015 do not annotate the purpose for which the product has
been used.
