Chapter 1. Common provisions
Article 1 this regulation lays down provisions on the approval and management of pesticides in the form of plant protection products or biocidal products. The regulation is notified pursuant
— Chapter 14. section 8 of the environmental code in terms of Chapter 1. section 4, Chapter 2. 4, 8, 9, 17 to 19, 21 and 22, § § § the first and second paragraphs 23, 24, 26 and 27 sections, section 28, first paragraph, section 30, paragraph 32, 33-35, § § § 36, first and second paragraphs, paragraphs 37 to 42, paragraph 43, paragraph 44, paragraph 47, paragraphs 50 to 52, paragraph 53, 54, 55 section 56, 57, § § § 58 first subparagraph, first and second subparagraphs, paragraph 59 , 60 – 62 sections 63 and paragraph, Chapter 3. Article 1, second paragraph, 5, 7, 8, 11 to 15 and 17 sections, section 18, first paragraph and second paragraph, first sentence, paragraph 19, paragraph 20 and 21 of the first sentence of the first subparagraph and second subparagraph, and Chapter 4. 1 and 3-4 paragraphs, paragraph 16, 23 to 27 sections and section 30 of the first sentence,
— Chapter 14. section 11 of the environmental code in terms of Chapter 4. 4 – 14, 16 and 18 to 22 sections,
— Chapter 14. section 19 of the environmental code in terms of Chapter 2. 5, 10, 29, 30, 45 and 46 §§, Chapter 3. 9 and 10 section and Chapter 4. 25, 28 and 29 sections, – Chapter 8. section 11 of the Constitution in terms of Chapter 2. paragraphs 14 and 25, and
– Chapter 8. section 7 of the Constitution in respect of the other provisions.
Regulation (2015:375).
section 2 of this regulation supplements
1. the environmental code,
2. 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 and
91/414/EEC, and
3. 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.
Rules on pesticides containing nematodes,
insects or Arachnids found in Regulation (2000:338) if
biocidal products containing nematodes, insects or
Arachnids and Regulation (2006:1010) on plant protection products
containing nematodes, insects or Arachnids.
Expression of the regulation
section 3 unless otherwise specifically provided for in this regulation,
expression of the regulation has the same meaning as in chapter 14.
the environmental code, Regulation (EC) No 1107/2009 and Regulation (EC)
No 528/2012.
paragraph 4 for the purposes of this regulation,
Distributor: wholesaler, retailer, sales person, vendor
or other natural or legal person providing
a plant protection product on the market,
chemical plant protection products: chemical product which is a
plant protection products pursuant to Regulation (EC) No 1107/2009;
Municipal Board: Board exercising municipal functions in
environmental and health protection,
provide on the market: to professionally against payment
or free ship for distribution or use, whether
delivery not only to the transport of someone else's
sheet,
Supervisor: the Government Department or the Municipal Board
exercise operational supervision pursuant to
environmental protection Regulation (2011:13),
qualifications: evidence confirming the sufficient knowledge of
the topics that are included in a course plan according to this regulation,
equipment used for dispersal of plant protection products:
apparatus specifically designed for the dissemination of
plant protection products, including nozzles, manometers, filters,
strainers, devices for tank cleaning and other accessories
is necessary for the unit to function effectively, and
Road range: land or space that has been used for a
way, the operation of a road or the use of a road.
Exemptions from environmental code requiring approval
4 a of the requirement of consent in chapter 14. section 4 of the environmental concerns
no chemical or biotechnical organisms
subject to approval in accordance with Regulation (EC) no
1107/2009, in its original version, or regulation (EU)
No 528/2012, in wording pursuant to European Parliament and Council
Regulation (EU) No 334/2014. Regulation (2015:140).
Defence activities
§ 5 in the case of activities and measures in the armed forces,
The Swedish fortifications Agency, the Swedish defence materiel administration and Defence
Radio establishment, the tasks pursuant to this Regulation shall
carried out by the municipal board instead filled by
General physician.
Supervision fees, appeals and penalties
section 6 of the Regulations 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, 19-21, 25 and 29 to 32 sections
environmental protection regulation.
paragraph 7 of the rules relating to fees for the examination and supervision is available in
Regulation (2013:63) if the pesticide charges as well as in
Ordinance (1998:940) if the fees for the examination and supervision
According to the environmental code.
section 8 provisions on appeal, see Chapter 19. 1 §
the environmental code.
section 9 provisions for penalties and forfeiture can be found in chapter 29.
the environmental code. Provisions on miljösanktions charges, see
30 Cape. the environmental code and the Regulation (2012:259) if
miljösanktions fees.
Chapter 2. Plant protection products
EU plant protection product regulation
Article 1 of Regulation (EC) No 1107/2009 provides for
authorisation of plant protection products, as well as concerning the placing on the
the market, use and control of plant protection products in
The European Union.
section 2 of the Swedish Chemicals Agency examines the questions on licensing,
authorization, waiver, and other measures should be examined in
Member States under Regulation (EC) No 1107/2009. Before
The Swedish chemicals agency determines such a question to the inspection
hear
1. The State's farming and Food Administration, if it is not
obviously unnecessary, and
2. the National Board of forestry, forest land is concerned.
paragraph 3 of the Chemicals Inspectorate is the competent authority and
coordinating authority under article 75(1) and 75(2) of
Regulation (EC) No 1107/2009, in wording, in accordance with Council
Regulation (EU) no 518/2013.
section 4 of the Swedish Chemicals Agency may announce regulations
necessary by reason of Regulation (EC) No 1107/2009, in
the wording according to Council Regulation (EC) no 518/2013.
Notice of amended classification or labelling
§ 5 If a plant protection product classification or labelling
amended in accordance with the regulations as the Swedish Chemicals Agency has
announced on the classification and labelling or according to
European Parliament and Council Regulation (EC) no 1272/2008 on
classification, labelling and packaging of substances and
mixtures, amending and repealing directives 67/548/EEC
and 1999/45/EC, and amending Regulation (EC) No 1907/2006,
for the person who has the authorization applies to
plant protection product shall immediately notify the Swedish Chemicals Agency
If the change.
Access to information in the registry
clause 6 of article 67(1) of Regulation (EC) No 1107/2009
provisions on the obligation of manufacturers, suppliers,
distributors, importers, exporters and professional
users of plant protection products to keep records and to
request, make the registry available to the competent
authority. The supervisory authority is such a competent
authority.
section 7 of the public can, pursuant to article 67(1) of Regulation (EC) no
1107/2009, request access to the information in a
records referred to in paragraph 6. If the regulatory authority may such
request, to the regulatory authority urgently require
the information from the registry.
Privilege classes
section 8 When a plant protection product authorised under Regulation (EC)
No 1107/2009, Swedish Chemicals Agency assess health product
and environmental risks with regard to the scope and
assign the product to
– class 1, if because of the risks involved in the use
special knowledge is needed to handle the vehicle safely
way,
– class 2, if for other reasons necessary special knowledge for
to handle the vehicle safely, and the vehicle will not
be assigned to class 1, and
– class 3, if the vehicle is not to be assigned to class 1 or
2.
§ 9 the Swedish Chemicals Agency must notify the closer
provisions on the criteria set out in section 8 of the assigning
plant protection products to the classes.
Swedish label
section 10 of a plant protection product available on the market in
Sweden shall be marked on the Swedish.
Education and qualifications
11 § Users of plant protection products should be offered training
providing adequate knowledge of the subjects listed in annex
I to 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. Training
to be provided by
1. The State's agricultural work, in terms of use
a) in agriculture, forestry, park maintenance or
gardening,
b) on land for apartment buildings,
c) on farms to schools and kindergartens,
(d)) on the playgrounds that the public has access to,
e) in sports and leisure facilities,
(f)) in the planning and public works,
g) on roads and embankments,
h) on grusytor and other very permeable surfaces, and
in) on the surfaces of asphalt or concrete, or other paved
materials,
2. The public health agency, for the use in and
near warehouses or other storage areas, and
3. the working environment authority, as for other use.
12 § Training according to § 11 shall consist of a basic education
and a training and should end with a
proficiency test. The programme shall be implemented in accordance with a
curriculum decided by the authority offers
the training.
Before the syllabus is decided, it shall hear the
The Swedish Chemicals Agency and other relevant authorities.
paragraph 13 of the Swedish Chemicals Agency shall offer such training as
referred to in section 11 to distributors of plant protection products.
The programme shall be implemented in accordance with a curriculum
decided by the Swedish Chemicals Agency and ends with a
proficiency test.
Before the syllabus is decided to the Swedish Chemicals Agency hearing
The State's agricultural work and other relevant authorities.
section 14 of the State's agricultural work and the Swedish Chemicals Agency may, within
their respective areas of responsibility, provide for the
the County Board shall offer such training referred to in 11 and
13 sections and on how the County Board will conduct the training.
section 15 of the authority or the County Administrative Board has given a
training under 11, 13 or section 14 shall issue a
training certificates to those who have participated in such a
education and passed a proficiency test with approved
results.
16 §/expires U: 2016-04-15/
The authority provides training in accordance with the
11 or section 13 shall recognise certificates issued
by an authority in another country within the European Union
or the European economic area, on the proof
evidence of adequate knowledge of the subjects included in the
Curriculum Authority has decided under section 12 or 13.
16 section/entry into force: 04/15/2016
Provisions on temporary mobility and recognition of qualifications acquired or recognised in another State within the European economic area (EEA) or Switzerland, see law (2016:145) on the recognition of professional qualifications and in the regulations issued in connection with the Act. Regulation (2016:176).
section 17/expires U: 2016-04-15/
The authority provides training in accordance with section 11 or 13
may, within its area of responsibility, provide for
1. how long a certificate to be valid, and
2. What is required for recognition of a foreign
diplomas under section 16 and for how long a recognition shall
be valid.
section 17/entry into force: 04/15/2016
The authority provides training in accordance with section 11 or 13 may, within its area of responsibility, provide for the duration of a certificate shall be valid.
Regulation (2016:176).
Usage authorizations for plant protection products
section 18 of a plant protection product under section 8 are assigned to class 1
professional use only and only by the
such a use permit for a plant protection product in class 1
that covers the use for which the product is authorised.
section 19 of a plant protection product under section 8 are assigned to class 2
professional use only and only by the
such a use permit for a plant protection product in class 1
or in class 2 which covers the use for which the product is
approved for.
section 20 inquiries about licences under section 18 or 19
be reviewed by the
1. The State's agricultural work, in terms of use
a) in agriculture, forestry, park maintenance or
gardening,
b) on land for apartment buildings,
c) on farms to schools and kindergartens,
(d)) on the playgrounds that the public has access to,
e) in sports and leisure facilities,
(f)) in the planning and public works,
g) on roads and embankments,
h) on grusytor and other very permeable surfaces, and
in) on the surfaces of asphalt or concrete, or other paved
materials,
2. The public health agency, for the use in and
near warehouses or other storage areas, and
3. the working environment authority, as for other use.
section 21 of a use permit in accordance with section 18 or 19 shall be given
only to the
1. have the specific knowledge needed to manage
the vehicle in a safe manner, and
2. can view it with a valid certificate.
section 22 of a use permit in accordance with section 18 or 19 may only
is given for some time and should be reconciled with the conditions needed
with regard to the protection of human health or the environment.
section 23 of the authority under section 20 hearing questions about
use permit may, within its area of responsibility to inform
regulations on
1. what knowledge required under section 21 (1),
2. conditions in General to give permission, and
3. the period of validity of the authorization.
The regulations shall mean that the user should have achieved
certain age.
Before the authority makes such provisions, it shall hear the
The Swedish Chemicals Agency and other relevant authorities.
section 24 of the authority under section 20 hearing questions about
use permit may, within its area of responsibility give dispensation
from the requirement for diplomas in 21 § 2, if the user
have previously had permission to use plant protection products in
class 1 or 2 and there is a special reason. A
exemption shall be limited in time and shall relate to a maximum of one year.
section 25 of the State's agricultural work may provide for the
authorisation and exemption issues under section 20 or 24,
be heard by the State's agricultural work rather than to
the County Administrative Board.
The provision of plant protection products
section 26 A Distributor may provide plant protection products on the
the market only if:
1. the premises of the Distributor is someone who has a valid
diplomas, and
2. the certificate is available at
the sale to answer any questions about the use of
medium, risks to health and environment from the use and measures
to manage these risks.
paragraph 27 of the Swedish Chemicals Agency may provide for
exceptions from the requirement for diplomas in 26 § 1 too much
small distributors who only sells products
professional use.
section 28 of a plant protection product under section 8 are assigned to class 1
or 2 may be transferred only to the
1. have a use permit in accordance with section 18 or 19, or
have someone at home who has a use permit, or
2. intends to transfer the vehicle ahead and have someone with him who
have a valid certificate.
Provisions on the transfer of the plant protection product is
particularly hazardous chemical products can be found in the regulation
(2008:245) on chemical products and biotechnical organisms.
section 29 of The transferring pesticides for non-professional
users must provide information on the risks to human
health and the environment that the use of plant protection products is United
with, in particular on hazards, exposure, proper storage,
management, distribution and safe disposal, as well as on
low-risk option.
section 30 of the Swedish Chemicals Agency must notify the closer
regulations as necessary for the execution of 26 and
29 sections.
The use of plant protection products
section 31 of 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 and that limits the need for chemical
plant protection products used in cereal seed for growth regulation
and to facilitate harvest,
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.
32 § the State's agricultural work may provide for the
General principles of integrated pest management in accordance with
Annex III to Directive 2009/128/EC, in the original
the 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.
33 § anyone considering the use of plant protection products shall, if
multiple plant protection products or methods are available for
the same use and purpose, as far as possible
Choose the method or medium which is least harmful to
human health and the environment.
34 § in the choice of plant protection products, priority is given to
1. funds which are not dangerous for the aquatic environment according to
The Swedish Chemicals Agency's rules on classification and
labelling of chemical products or regulation (EC) no
1272/2008, the wording under Commission Regulation (EU) no
487/2013, and
2. products not containing alachlor, atrazine, anthracene,
benzene, brominated diphenyl ethers, pentabromodiphenylether,
cadmium or cadmium compounds, chloralkanes have, chlorfenvinphos,
Chlorpyrifos, klorpyrifosetyl, 1.2-dichloroethane, dichloromethane,
di (2-ethylhexyl) phthalate (DEHP) diuron endosulfan,,, fluoranthene,
hexachlorobenzene, hexachlorobutadiene, hexachlorocyclohexane,
isoproturon, lead, lead compounds, mercury,
Mercury compounds, naphthalene, nickel, nickel compounds,
Nonylphenol (4-Nonylphenol), octylphenol,
4-(1,1 ', 3, 3 '-2,2'-methylene-bis-6-(2H-benzotriazol-2-yl)-4-Tetra-methyl-butyl-1,1,3,3-phenol-phenol), pentachlorobenzene,
pentachlorophenol, poly aromatic hydrocarbons, (benzo (a) pyrene),
(benzo (b) fluoranthene, benzo (g, h, i) perylene),
(benzo (k) fluoranthene, indeno (1,2,3-cd) pyrene), simazine,
tributyltin compounds, (tributyltennkatjon), trichlorobenzene,
trichloromethane, chloroform or trifluralin.
35 section On using plant protection products shall, as far as
possible,
1. use the most efficient distribution technology,
2. take measures that minimize the risk of contamination from outside
the area where the distribution takes place,
3. determine and follow safety distance when applying outdoors
that in the circumstances at the site of
the handling is needed to protect water supplies, groundwater,
Lakes and rivers, and surrounding land from the effects of
plant protection products, and
4. otherwise take the precautions with regard
the circumstances at the place of management is needed for
to protect human health and the environment.
36 § environmental protection agency may provide for
1. safety distances and precautions according to § 35
needed to protect water supplies, groundwater, lakes and
rivers and surrounding land from the effects of
plant protection products and to protect human health and the
the environment,
2. prohibited without the permission of the local Government Board
professional use of plant protection products within a
water protection areas, and
3. obligation to inform about accidents or incorrect
management at the distribution of plant protection products.
Regulations referred to in the first subparagraph 2 shall not apply to an
water protection areas or parts of a water protection area
covered by the provisions adopted by virtue of Chapter 7. 22
§ environmental regulations prohibiting the use of plant protection products.
Before the environmental protection agency Announces rules referred to in the first
paragraph, the authority hearing the State's agricultural work,
The Swedish Chemicals Agency, NFA, maritime and
the water authority, the Swedish forest Agency and geological
survey.
Special restrictions for certain uses
37 § plant protection products may not be used in meadows or
pasture land that is not suitable to plow but can be used
for mowing or grazing.
section 38 the State's agricultural work must notify such provisions if
derogation from the prohibition provided for in paragraph 37 that is needed to prevent
the spread of invasive alien species.
section 39 the Municipal Board may, in the particular case, give
exemption from the prohibition in section 37, if there are special reasons,
the plant protection product are approved by the Swedish Chemicals Agency and
the use is consistent with the terms of the marketing authorisation.
39 a of Chemical plant protection products may not be used to combat
1. vegetation in lakes, rivers, wetlands and other water bodies, or
1
2. harmful nematodes in the soil at cultivation of crops intended for the production of food or feed. Regulation (2015:375).
39 b of Chemical plant protection products are fungicides may not be used to treat fruit and potatoes after harvesting.
Regulation (2015:375).
§ 39 c 39 39 prohibitions in paragraphs a and b does not apply to the use of plant protection products as the Swedish Chemicals Agency has decided to allow, in accordance with article 53 of Regulation (EC) No 1107/2009, in the original wording. Regulation (2015:375).
section 39 d of the State agricultural works, in the particular case waive the bans in 39 39 (a) and (b) sections, about 1. the vehicle is approved for the purpose by the Swedish Chemicals Agency,
2. There are special reasons, and 3. the control or treatment that the exemption concerns cannot be met with non-chemical methods.
Regulation (2015:375).
40 § it is forbidden without special permission of the
Municipal Board Professional using plant protection products
1. the land for apartment buildings,
2. on farms to schools and kindergartens,
3. on the playgrounds that the public has access to,
4. in the parks and gardens where the public has access,
5. in the field of sports and leisure facilities,
6. in the planning and public works,
7. on the road and on grusytor and other very
permeable surfaces, and
8. on the surfaces of asphalt or concrete, or other paved
material.
The permit requirement in the first paragraph 7 and 8 do not apply
the use of plant protection products
1. on roads, in order to prevent the spread of invasive
alien species or other species covered by
rules on control that State's agricultural work has
notified, or
2. on the embankments.
section 41 is prohibited without prior written notification to the
Municipal Board Professional using plant protection products
1. on roads, in order to prevent the spread of invasive
alien species or other species covered by
rules on control that State's agricultural work has
announced,
2. on the embankments, and
3. in areas not subject to authorisation under
40 section and have a continuous area exceeding 1 000
square meters where the public may travel freely.
The notification requirement of the first paragraph 3 does not apply to the use
on arable land.
The notifiable activities may commence no sooner than
four weeks after the notification has been made, unless the Board
determines otherwise.
the provisions of § § 37 42, 40 paragraph 4 – 8 and 41 §
does not apply to the use which
1. has the character of spot treatment, and
2. has such a limited extent that human health and the
the environment is not likely to be damaged.
43 § Swedish environmental protection agency
1. notify the details relating to the exemption under section 39, and
2. in the case of use of plant protection products than
the use of forest land provide for
enforcement of sections 40 to 42.
Before the environmental protection agency will notify such provisions shall
the work told the State's agricultural work, the Swedish Chemicals Agency,
Marine and water, National Board of forestry, Sweden
geological survey.
44 § Forestry Board may, in respect of the use of
plant protection products on forest land, provide for
the enforcement of paragraph 41 (3) and section 42
Before the forest Board such regulations should work
hear the environmental protection agency, the State's agricultural work,
The Swedish Chemicals Agency, marine and water and
The geological survey.
Information to the public
section 45 The intending to spread pesticides in areas where
the public may travel freely, with the exception of arable land, the
before the distribution is made to inform about it on clearly visible
appropriation.
The first subparagraph shall not apply to such distribution that has character
the spot treatment and who has such a limited scope
to human health and the environment are not likely to be damaged.
46 section environmental protection agency may provide for how
the obligation to provide information under section 45 is to be performed.
Exemption from the prohibitions in chapter 14. section 7 of the environmental code
47 § Swedish environmental protection agency in the particular case give dispensation
from the prohibition against scattering from aircraft in chapter 14. 7 §
first subparagraph, the environmental code, in the case of plant protection products, if it
There are serious reasons and
1. dispersing from aircraft is the only working
option to achieve the purpose of the dissemination or
means clear benefits for human health or the environment
compared to ground-based distribution options,
2. plant protection product are approved by the Swedish Chemicals Agency and
the use is consistent with the terms of the authorisation,
3. a person who intends to carry out the spread has a
licences under this regulation for
the plant protection product, and
4. the area covered by the intended dissemination does not
is adjacent to residential areas.
Before the environmental protection agency provides such a dispensation to work hearing
National Board of forestry, the State's agricultural work, the Swedish Chemicals Agency
and marine and water.
48 § the Swedish Chemicals Agency, in each case provide
exemption from the prohibition in chapter 14. the second subparagraph of paragraph 7 the environmental code
to spread pesticides for the control of lövsly, if the
required for scientific examination.
49 § National Board of forestry, in the particular case waive
prohibition in chapter 14. the second subparagraph of paragraph 7 the environmental code to spread
plant protection products for the control of lövsly, if the
to the location and nature of the forest, forest stock
composition, the effect on living conditions
for plant and animal life, and other general interests are not
reasonably possible that by clearing using mechanical means
meet the requirement if the regrowth of forest in section 6 of the forestry law
(1979:429).
50 § A dispensation according to 47, 48 or 49 § shall be combined with the
conditions needed from health and environmental protection point of view. A
such exemption may be subject to requirements for notification before
the plant protection product is used.
Application equipment
51 section Equipment for professional distribution of plant protection products
must be in good condition, suitable for the purpose and well
calibrated.
the entry into force of § 52/in: 2016-11-26
Equipment for professional distribution of plant protection products
may be used only if the user of the equipment can view
It is approved by the State's agricultural work.
53 § State agricultural works, notify
1. the regulations on the requirements needed to
comply with section 51,
2. regulations for exceptions to the requirement for consent in section 52,
3. regulations on the inspection of application equipment, and
4. regulations on the requirements of the controlling
application equipment and the equipment used in
the control.
Before the Agriculture Department will notify such provisions to the work
hear the Swedish forest Agency, the environmental protection agency and
The Swedish Chemicals Agency.
section 54 of the State agricultural works, approve the application equipment
According to section 52, if
1. the equipment has been checked by someone who has their
control activities are reported in the Agriculture Department and the
carried out the inspection
a) meets the requirements for inspection activities
According to the rules given under paragraph 53
paragraph 4, and
(b)) has established a protocol that indicates that the control
been made, the time of the check and what it included and
that the equipment meets the requirements of the regulations
notified pursuant to paragraph 53 1 and 3, or
2. equipment has been inspected and approved in a different
country in the European Union or the European economic
area and the check shows that the equipment
to satisfy the requirements referred to in 1 (b).
An approval shall be limited so that it does not apply
until the day that is three years after the
the control that is the basis for approval.
55 § the State's agricultural work may provide for
1. requirements for such protocols as referred to in paragraph 54 1
(b), and
2. approval for a type of equipment shall have a
other validity than that set out in paragraph 54.
Before the Agriculture Department will notify such provisions to the work
hear the Swedish forest Agency, the environmental protection agency and
The Swedish Chemicals Agency, unless it is unnecessary.
Documentation in the dispersion
56 § The professional use of plant protection products shall
document any use of plant protection products and enter
the safety distance that have been held during propagation that occurs
outdoors, what other precautions for the protection against
environmental impacts have been taken at distribution, and of which
the purpose of the plant protection product has been used.
57 § the State's agricultural work may provide for
1. the documentation requirement in section 56,
2. how the record keeping, as referred to in article 67(1) of
Regulation (EC) No 1107/2009, in wording, in accordance with Council
Regulation (EU) no 518/2013, apply to professional
users, must be fulfilled,
3. requirements for the documentation needed to
assess whether sufficient account has been taken of the pollinating
insects in the distribution of plant protection products, and
4. requirements for documentation of integrated pest management
applied.
Before the Agriculture Department will notify such provisions to the work
hear the environmental protection agency, the Swedish Chemicals Agency and
The Swedish forest Agency.
Management of plant protection products when not in use
58 § When a plant protection product is not used, it is stored and
the remainder is managed in a manner that does not present any risk to
damage to human health or the environment.
Dilution and mixing of pesticides before spreading
as well as cleaning after the dissemination of the equipment used
shall be carried out in such a way that it does not involve any risk
for damage to human health or the environment.
Regulations on the management of waste, see Chapter 15.
environmental and waste regulations (2011:927).
59 § environmental protection agency may provide the additional regulations
on the storage and handling of plant protection means
in order to protect human health and the environment.
Before the environmental protection agency will notify such provisions shall
the work told the State's agricultural work, the Swedish Chemicals Agency and,
on issues related to forest land, the Forestry Board.
Goods which have been treated with plant protection products
60 § cereals, potatoes or other seed that has been treated
with plant protection products may only be used as the seed.
61 § Packaging that has been used for the storage of seed
referred to in § 60 may not be used for other purposes.
62 § conifer seedlings which have been treated with a chemical
plant protection products may be introduced to Sweden only if the vehicle
According to Regulation (EU) No 1107/2009, in wording, in accordance with Council
(EU) no 518/2013, is approved for the use of any of the
The Member States of the European Union.
63 § the Swedish Chemicals Agency, in each case provide
exemption from the prohibition in § 62, if there are special reasons.
Before the exemption issue is determined to be the Swedish Chemicals Agency hearing
The Swedish forest Agency.
National action plan, risk indicators and priorities
64 § State agricultural work to take forward proposals for national
action plan in accordance with article 4 of Directive
2009/128/EC, in the original wording.
The Agriculture Department should continuously evaluate national
the action plan and will be for the Government to submit proposals to the
changes as deemed necessary.
When the Agriculture Department prepares a proposal for a national
action plan or changes in the plan should work hear
The Swedish Work Environment Authority, The Environmental Protection Agency, The Swedish Chemicals Agency,
Marine and water, the Swedish forest Agency and other interested
authorities and otherwise follow what indicated on public
participation in article 4(5) of Directive 2009/128/EC in
original wording.
section 65 of the State agricultural works
1. calculate harmonised risk indicators as referred to in article
15(1) of Directive 2009/128/EC, in the original wording,
2. identify trends for the use of certain active
substances, and
3. identify priorities, such as active substances, crops,
regions or cultivation methods that require special
attention, or good practices that can serve as an example for
to achieve the objective of reducing the risks associated with
pesticides and to encourage the development and
the introduction of integrated pest management and of alternative methods
in order to reduce dependency on plant protection products.
Agriculture Department shall make the information referred to in the first
paragraph accessible to the public.
66 § the Swedish Chemicals Agency shall provide the State's agricultural work it
help needed for the Agriculture Department to carry out
their duties under section 65.
Chapter 3. Biocidal products
section 1 of this chapter contains provisions on the provision
on the market and use of biocidal products.
For biocidal products which are not subject to approval
under Regulation (EC) No 528/2012 also applies to Chapter 4.
EU: s biocidförordning
section 2 of the Regulation (EC) No 528/2012 contains provisions on
"making available on the market and use of
biocidal products.
Prohibitions on the provision of certain biocidal products on
the market can be found in article 4 of Commission Regulation (EC)
No 1451/2007 of 4 december 2007 on the second phase of the
ten-year work programme referred to in article 16(2) of
European Parliament and Council Directive 98/8/EC concerning the placing
biocidal products on the market.
paragraph 3 of the Swedish Chemicals Agency examines the questions on licensing,
authorization, waiver, and other measures should be examined in
The Member States of the European Union under Regulation (EC) no
528/2012, in wording pursuant to European Parliament and Council
Regulation (EU) No 334/2014. Before The Swedish Chemicals Agency
determine any such question should inspection told the NFA
and the State's agricultural work, unless it is clear
unnecessary.
section 4 of the Swedish Chemicals Agency is the competent authority
referred to in article 81 of Regulation (EC) No 528/2012, in
the wording according to Regulation (EU)
No 334/2014.
paragraph 5 of the Chemicals Inspectorate must notify the rules
necessary by reason of Regulation (EC) No 528/2012, in
the wording according to Regulation (EU)
No 334/2014.
section 6 of the General physician, in the particular case waive
requirements of Regulation (EC) No 528/2012, in wording as
European Parliament and Council Regulation (EC) No 334/2014;
When it is necessary because of the Swedish defence interests.
Before such an exemption is given, the General physician consult
The Swedish Chemicals Agency.
Privilege classes
7 § When a biocidal product authorised under Regulation (EC) no
528/2012 or Chapter 4. This regulation, the health
and environmental risks to be assessed by reference to the area.
On the basis of such an assessment, the product should be assigned to
any of the following classes:
– class 1, if the product may only be used professionally by
Anyone who has a use permit,
– class 2, if the product may only be used professionally,
and
– class 3, where the product can be used by everyone.
section 8 of the Swedish Chemicals Agency must notify the
the criteria set out in section 7 for entry of biocidal products
to classes.
Swedish label
§ 9 a biocidal product available on the market in
Sweden shall be marked on the Swedish.
Provision of biocidal products
10 § whoever on the market provide a biocidal product
to non-professional users in the provision
inform that the product must be used in a secure
way.
The information shall
1. contain an invitation to always before use read the
label found on the packaging and other
product information, and
2. disclosed in such a way that it clearly
from other information.
Knowledge requirements for use of biocidal products
section 11 of a biocidal product under section 7 are assigned to class 1,
be used only by those who have the specific knowledge
required to handle the product in a safe manner.
11 a §/entry into force: 04/15/2016
Provisions on temporary mobility and recognition of qualifications acquired or recognised in another State within the European economic area (EEA) or Switzerland, see law (2016:145) on the recognition of professional qualifications and in the regulations issued in connection with the Act.
Regulation (2016:176).
section 12 of the Swedish Chemicals Agency may provide for
1. a biocidal product under section 7 are assigned to class 2
may be used only by those who have the specific knowledge
required to handle the product in a safe way, and
2. that the user of a biocidal product in accordance with article 7 of
assigned to class 1 or 2 will have reached certain age.
paragraph 13 of the public health authority may provide for the
knowledge required by section 11 in respect of measures against
vermin and pests according to Chapter 9. section 9 of the Environment Act.
Regulations may require that the user should have
reached certain age.
section 14 of the Swedish work environment authority may provide for the
knowledge required by section 11 in the case of other
use than action against vermin or pests under 9
Cape. section 9 of the Environment Act. Regulations may require that the
the user should have reached a certain age.
Licences for biocidal products
section 15 a biocidal product under section 7 are assigned to class 1,
used only by the person who has a use permit for
biocidal products which include the use to which the product is
approved for.
section 16 Questions about usage permission for biocidal products
be reviewed by the
1. The public health agency, with regard to measures against vermin
and pests according to Chapter 9. section 9 of the Environment Act, and
2. the working environment authority, as for other use.
section 17 a use permit may be granted only to those who can
demonstrate that he or she has the specific knowledge required
According to section 11 and the provisions adopted by the
The public health authority under section 13 or the work environment authority
According to section 14.
section 18 of the public health agency and the Swedish work environment authority may notify the
details relating to the
1. conditions for giving an authorization under section 15,
and
2. the period of validity of the authorization.
Regulations may require that the user should have
undergone a special training. Before a regulation
be communicated to the authority shall hear the Swedish Chemicals Agency.
Handling of biocidal products
section 19 When a biocidal product is not being used, it is stored and in
the rest is managed in a manner that does not present any risk to
human health or the environment.
Regulations on the management of waste, see Chapter 15.
environmental and waste regulations (2011:927).
section 20 of the environmental protection agency may announce the rules from
health and environmental protection are needed in case of
1. precautions for handling of biocidal products,
2. requirements for registration or authorization for commercial use
of biocidal products,
3. requirements for documentation on handling of biocidal products,
and
4. obligation to inform about the proliferation of biocidal products
in a place that the public has access to.
Before the environmental protection agency will notify such provisions shall
the work told the State's agricultural work, the public health agency,
The Swedish Chemicals Agency and marine and water.
Exemption from the prohibition of the dissemination of aircraft
section 21 in respect of the dissemination of biocidal products from aircraft
get the environmental protection agency in the particular case waive
prohibition in chapter 14. paragraph 7 of the first paragraph, the environmental code, if the
There are serious reasons. Before the environmental protection agency provides such a
exemption, the Agency told the Swedish Chemicals Agency, maritime and
the water authority, the State's agricultural work and
The Swedish forest Agency.
A waiver should be reconciled with the conditions
needed from health and environmental protection point of view.
Chapter 4. Biocidal products which are not covered by the EU standards on
approval
section 1 of This chapter only applies to biocidal products in accordance with
Article 89(2) of Regulation (EC) No 528/2012, in wording as
European Parliament and Council Regulation (EC) No 334/2014;
not subject to approval in accordance with the regulation.
Regulation (2015:140).
Approval
section 2 of the Swedish Chemicals Agency examines issues concerning the approval according to
Chapter 14. section 10 of the environmental code of such biocidal products referred to
in section 1. Before the Swedish chemicals agency determines such a question to be
inspectorate told the NFA and the State's agricultural work,
unless it is obviously unnecessary.
paragraph 3 of the Swedish Chemicals Agency shall 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. Regulation (2015:140).
3 a of the Swedish Chemicals Agency may grant an exemption from the requirement of
the approval in chapter 14. section 4 of the environmental code, if there are special
reasons. A waiver should be reconciled with the conditions required by
regard to the protection of human health and the environment.
Regulation (2015:140).
4 of a biocidal product shall be authorised only if the product is
acceptable from the point of view of protection for health and the environment and is needed in
control purposes.
When the authorisation concerns a product which is the same as a
previously approved product, the new product approval
only if the applicant demonstrates that all reasonable measures have
taken, in order to avoid unnecessary animal testing,
agree with the person who has the right to documentation for
the previously approved product on how data on the
previously approved product and its active substance,
use common to both products.
A biocidal product shall not be authorised if its designation can
is considered to be misleading as to the product's composition,
mode of action and properties in General, or may lead to
confusion with other biocidal product or a
plant protection products.
5 § the Swedish Chemicals Agency may provide for the
conditions for approval to apply under the
regarding the composition, mode of operation and
properties in General and the need on the basis of
control purposes.
section 6, an application for authorisation or
Amendment of an authorisation shall be made by, or on behalf
by the responsible or will be responsible for
the product is provided for the first time on the Swedish
the market. The applicant shall have a permanent Office in a country
within the European Union or the European economic
area.
section 7 of the application for approval shall include a documentation
about the product and its active substance.
section 8 in respect of active substances on the market prior to the
on 14 May 2000 and biocidal products containing them
active substances applies to information in documentation
attached to the application for approval must be used for the benefit
for other applicants at the earliest after 31 december 2024.
If the information is protected under the provisions of law or
other regulation and the protection will expire before 31 december
2024, the first subparagraph is not that the information is used
After the previous time.
The first subparagraph shall not apply if the applicant has permission to
using the data from the originally submitted
documentation or from someone whose right to give permission
to the use of the documentation can be traced back to the
which originally gave it up.
§ 9 instead of requiring documentation may
The Swedish Chemicals Agency accept that the applicant refers to the
information supplied in respect of a previously approved
biocidal product if the applicant demonstrates that the new product is similar to
the past and contain the same active substances with the same
of purity and nature of impurities.
The first subparagraph shall not apply in contravention of section 8 or
Article 60 of Regulation (EC) No 528/2012, in wording as
European Parliament and Council Regulation (EC) No 334/2014.
section 10 in connection with the authorisation of a biocidal product,
The Swedish Chemicals Agency, if the applicant so requests, establish a
frame formulation that implies a specification for a group
biocidal products with the same application and the same
user category.
11 § instead to require documentation under section 7,
The Swedish Chemicals Agency to put such a framework formulation referred to
in paragraph 10 of the basis for a subsequent approval by a
biocidal product, if the latter product compared to the
previously approved product has the same use and
user category and
1. have a lower content of active substance, and
2. the content of the rest of the non-active substances, pigments,
dyes or perfumes are the same, or have been altered without
the risk level has increased or decreased the efficiency.
section 12 of a decision under section 11 if adding a frame-formulation
the basis for a subsequent approval may only be granted if
It is in accordance with section 8 and if the applicant can show their
permission to add the frame formulation as the basis of their
the application. Such a decision may not be announced later than 60
days from receipt of the application.
paragraph 13 of the Swedish Chemicals Agency may provide for the
documentation and samples needed to authority
to carry out its review.
section 14 does not require a new authorisation to a
other names provide a biocidal product on the market in
essence is similar to a product that is approved
under this regulation, of the like product
1. contains the same active substance in the same level as the
approved product,
2. is manufactured according to the same method as the approved
the product,
3. have the same functions and features as the approved
the product,
4. meet the same security requirements as the approved
the product,
5. have a title that may not lead to confusion with the
approved product or would otherwise be contrary to the provisions of paragraph 4 of the third
subparagraph, and
6. is enrolled in the Swedish Chemicals Agency and notification
contains the documents necessary to demonstrate compliance with the requirements of
1 – 5 are met.
section 15 of the Swedish Chemicals Agency shall keep a record of the name
notified in accordance with section 14.
section 16 in order to ensure that such rules referred to in
section 5 is followed, the Swedish Chemicals Agency decide that approval
shall be subject to special conditions in addition to the following
of the provisions on the management, classification,
packaging, labelling and other product information. The
special conditions to be specified in the authorisation.
Before the Swedish Chemicals Agency decides on any specific
conditions are really hear the Food Administration, Statens
agricultural work and other relevant authorities, if it is not
obviously unnecessary.
section 17 Of chapter 14. section 10 of the environmental code indicates that an approval
may be granted for a maximum of 10 years.
section 18 of the period of validity of an authorisation may be extended if the
the conditions for approval are still fulfilled.
The Swedish Chemicals Agency may decide that approval shall
should be extended for the time required for this test.
Review and termination of authorisation
section 19 of an approval shall be reviewed, if there is evidence that
indicates that a condition referred to in section 5 is not
met.
In the case of a review under the first paragraph,
The Swedish Chemicals Agency, require that the holder of the authorisation
provide the information needed for the review. Inspection
may decide that approval shall be extended for the time
needed for the review and for the provision of the information
required.
section 20 of an approval may be amended
1. If the applicant for the approval request and State
the reasons for it, or
2. in the case of the terms and conditions of use, on an amendment to the
the light of new scientific and technical knowledge is justified
from the point of view of human health or the environment.
A change may be made only if the conditions referred to in
§ 5 are still fulfilled.
section 21 of an approval may be amended in respect of the
area of use.
A change may be made only if the conditions referred to in
§ 5 are still fulfilled.
section 22 of an approval shall be revoked, if
1. the conditions referred to in section 5 is no longer
fulfilled, or
2. false or misleading information has been provided
with respect to the facts on the basis of
the approval.
An authorisation may also be cancelled if the applicant for
the approval request and state the reasons for it.
section 23 in connection with that termination or modification of an authorisation
Swedish Chemicals Agency may decide that remaining stocks of
the product must be disposed, stored, made available on the
the market and used for some time. Time to be determined
in view of what caused the suspension.
The decision should not mean that a product is provided on
market or used in contravention of other provisions that are
applicable to the product.
The Swedish Chemicals Agency must notify the
implementation of the first subparagraph.
Production, storage and transport of biocidal products
approved in other countries
section 24 a biocidal product shall be manufactured, stored, or
be transported even if it is not approved by
The Swedish Chemicals Agency, if it is approved in another country
within the European Union or the European economic
area and is not intended to be used in Sweden.
Packaging and labelling
Article 25 of the Swedish Chemicals Agency must notify the regulations on
packaging and labelling of biocidal products as needed with
regard to the protection of human health and the environment.
paragraph 26 of a biocidal product shall not be made available on the market
If it is not packaged and labelled according to the provisions
The Swedish Chemicals Agency has notified under section 25.
Use
section 27 a biocidal product to be used in a manner that is
complies with the conditions for approval referred to in
paragraph 5, the terms have been decided in accordance with section 16 and the
information provided on the label under section 25.
The professional use of a biocidal product shall,
combining physical, biological, chemical or other
methods appropriately restrict the use to which
is absolutely necessary.
Duty to notify
section 28 of The manufacturing or in the market provides a
biocidal product shall immediately notify the Swedish Chemicals Agency
If, after the approval will generate new information on
1. that the product or residues of an active substance in the
can have harmful effects on human health, ground water
or the environment in General,
2. the composition of the product,
3. the origin of an active substance or composition,
4. development of resistance,
5. how the product is packaged, or
6. other circumstances that may be relevant for the
continued approval.
section 29 of the Swedish Chemicals Agency may announce detailed rules
If the notification obligation.
Temporary restrictions and prohibitions
30 § if there is reason to suspect that a
biocidal product presents an unacceptable risk to human health
or the environment, the Swedish Chemicals Agency temporarily restrict
or prohibit the use or sale of the product.
If the Inspectorate notifies such a decision, the inspection
immediately inform the European Commission and the other
Member countries of the European Union.
Transitional provisions
1. this Regulation shall enter into force on 26 november 2015
question about Chapter 2. 26 and 28 sections, on 26 September 2016 in relation to
Chapter 2. § 52 and 15 July 2014.
2. resolution on the authorization to use plant protection products in class 2
which has been granted in accordance with the Regulation (2006:1010) if
plant protection products before 15 July 2014, for the purposes of
Chapter 2. § 19 is considered permission to use
plant protection products in class 2.
3. Training of distributors according to Chapter 2. section 13 requires
not be offered before 1 January 2015.
4. in the case of the dissemination of plant protection products is made before the
1 January 2015 need documentation according to Chapter 2. 56-not
refer to plant protection product use purpose.
5. the provisions of Chapter 4. apply for the first time for
applications submitted to the Swedish Chemicals Agency after the
July 15, 2014.
