Introductory provisions
section 1 of this regulation is notified pursuant
— Chapter 14. section 8 of the environmental code in case of 4 – 5, 7, 25-28, 31, 32,
34, 41 and 44 to 50 sections,
— Chapter 14. section 11 of the environmental code in case of 9, 10, 19 to 23, 30 and
§§ 33,
— Chapter 14. section 19 of the environmental code in terms of 11, 29, 40 and 42 sections,
and
– Chapter 8. 7 and 11 of the Constitution in the case of other
provisions. Regulation (2014:429).
paragraph 2 of this regulation,
biocidal products directive: European Parliament and Council directive
98/8/EC of 16 February 1998 concerning the placing of
biocidal products on the market, as last amended by
European Parliament and Council Directive 2008/31/EC,
biocidal product: chemical or biological pesticides according to
the definitions in chapter 14. the environmental code and which are not
plant protection products in accordance with the Regulation (2006:1010) if
plant protection products,
low-risk biocidal product: biocidal product which contains no
other active substances other than those listed in annex IA
to the BPD and that do not contain any potentially
harmful substance,
basic substance: chemical substance which is listed in Annex IB
to the biocides directive and which are not predominantly used as
pesticides but which has some minor use as a
biocidal product either directly or diluted with a simple
diluent in a chemical product that is marketed for neither
control purposes or contains any substance as
of concern from health or environmental protection,
substance: substance that is not an active substance
but which has the property that it can have a negative effect on
humans, animals or the environment and is present or is produced in a
biocidal product in sufficient concentration to give
rise to such an effect,
active substance: any substance or micro-organism, including viruses or
mushroom, having general or specific action on or against
organisms whose presence is unwanted or harmful to people,
for human activity, for products that people use
or produces, for animals or for the environment, and
frame formulation: specification for a group of biocidal products with
the same use and user type.
In addition, the terms and expressions in this regulation the same
meaning as in chapter 14. the environmental code. Regulation (2008:258).
Scope of application
section 3 of this regulation only applies to biocidal 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.
Other provisions concerning biocidal products are available in 3 and 4.
Regulation (2014:425) on pesticides.
When this Regulation applicable to a biocidal product
are also covered by the regulation on pesticides, this
Regulation cannot be applied in violation of the regulation on
pesticides. Regulation (2014:429).
Approval
section 4 of the Swedish Chemicals Agency examines issues concerning the approval according to
Chapter 14. section 10 of the environmental code of biocidal products covered by
This regulation. Regulation (2014:429).
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 (2014:429).
repealed by regulation 6 (2014:429).
section 7 does not require a new authorisation to another
name place a biocidal product on the market that in everything
It is similar to a product that is approved in accordance with
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 product,
3. have the same functions and features as the approved
the product,
4. meet the same security requirements as the approved product,
5. have a title that may not lead to confusion with the
approved product or would otherwise be contrary to the provisions of section 10, and
6. is enrolled in the Swedish Chemicals Agency and the notification contains
the documents necessary to demonstrate that the requirements of 1-5 is
met.
The Swedish Chemicals Agency must keep a record of the name as
notified in accordance with the first paragraph. Regulation (2006:1049).
Conditions for approval
section 8, 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
placed on the market in Sweden. The applicant shall have a
permanent Office in a country within the European Union or the European
economic area. Regulation (2006:1049).
§ 9 the Swedish Chemicals Agency may provide for the
conditions for the authorisation should apply according to chapter 14.
section 10 of the environmental code regarding product composition,
mode of action and properties in General and the need on the basis of
control purposes. Regulation (2008:258).
section 10 of 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 or characteristics in General, or may lead to
confusion with a different pesticides.
Regulation (2006:1049).
Requirements for documentation
section 11 of the application for approval shall include a documentation
about the product and its active substance.
The Swedish Chemicals Agency must notify the regulations on
documentation and samples required in respect of
BPD or as otherwise necessary for the inspection
to carry out its review. Regulation (2006:1049).
section 12 is repealed by Regulation (2014:429).
section 13 Has been repealed by Regulation (2014:429).
14 repealed by Regulation (2014:429).
15 repealed by Regulation (2014:429).
16 repealed by Regulation (2014:429).
section 17 was repealed by Regulation (2014:429).
section 18 is repealed by Regulation (2014:429).
Use of information in matters concerning the authorisation of products
similar to previously approved products
§ 19 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 paragraph shall not be applied in violation of the provisions of
12-17 sections.
20 § in connection with the authorisation of a biocidal product,
The Swedish Chemicals Agency establish a frame formulation.
The inspection shall establish a frame-formulation, if the applicant
request it.
Instead of requiring documentation, Swedish Chemicals Agency
lay the frame formulation as a basis for subsequent approvals of
biocidal products. This assumes that the latter product
compared to the previously approved product
1. have the same use and user category, and
2. only differs in that the concentration of the active
the subject is lower than in the previous product and content of
the rest of the non-active substances, pigments, dyes or
perfumes varies or has been changed but that the risk level has
increased or decreased efficiency.
Decision on the application for approval under other
subparagraph shall be notified within 60 days of the application has
come in.
The second paragraph shall not be applied in violation of the provisions of
12-17 sections. Application of the second subparagraph also requires that the
the applicant indicates that he has permission to add
frame formulation as a basis for its application.
Mutual recognition
section 21 of a biocidal product that is licensed or registered in a
country in the European Union or the European economic
area shall at an applicant's request be approved or
registration, if the active substance is listed in the
the list in Annex i or IA of the biocides directive and
meets the requirements set out in the list.
When the Swedish Chemicals Agency receives an application referred to in
first subparagraph, shall decide whether to approve the inspection within the
120 days or decide on registration within 60 days.
The first paragraph shall not be applied in violation of the provisions of
12-17 sections or provisions as a result of Sweden's
membership of the European Union concerning the protection of
human health or the environment.
section 22 Despite section 21, Swedish Chemicals Agency decide that
provisionally refuse authorisation or registration. In so
cases, the provisions of this section.
If the Swedish Chemicals Agency believes that the product is not a
low-risk biocidal product and that the registration is in another
country, therefore, cannot be recognized, the following applies.
The inspection shall immediately notify the authority that
responsible for checking the documentation, see
If the product and try to reach an agreement with the authority
If the conditions which will apply to the product. If
the authorities do not reach agreement within 90 days,
matter be referred to the European Commission for
crucial.
If the Swedish Chemicals Agency consider that the product does not
meets the conditions referred to in section 9 and to
authorisation or registration in another country because
can not be recognized or may be acknowledged only with
additional terms and conditions, the following applies. The inspection shall
submit the case to the European Commission for
crucial. The inspection shall also inform the other
the countries of the European Union and the European economic
area. The handover and the notification shall
contain a description of the Inspectorate's assessment.
The report should also be provided to the applicant.
Regulation (2010:1191).
23 § notwithstanding section 21, Swedish Chemicals Agency
decide to refuse the authorisation or the registration of
biocidal products that are intended for the control of birds, fish
or other vertebrates than rodents. Such a decision
assume that a refusal can be justified and do not undermine
biociddirektivets purpose.
section 24 is repealed by Regulation (2014:429).
Conditions of an authorisation shall be accompanied by
section 25 As a biocidal 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
the product can be attributed to any of the following classes.
Class 1: the product may only be used for professional use
by special permit.
Class 2: the product may only be used for professional use.
Class 3: the product that may be used by everyone.
section 26 in order to ensure that such rules referred to in
section 9 is followed, the Chemicals Inspectorate after consultation with other
the authorities concerned may decide that approval shall be subject
with special conditions beyond that permitted by applicable
regulations on management, classification, packaging,
labelling and other product information. The specific terms and conditions
shall be indicated in the authorisation. Regulation (2008:258).
The period of validity
paragraph 27 of the 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 biocidal product is listed in annex I
or IA of the BPD, the approval will be given only for
time when the substance, as specified in the list, should be
included in the list. Regulation (2008:258).
section 28 of the period of validity of an authorisation may be extended if the
conditions for approval in section 9 is still
met. The Swedish Chemicals Agency may decide that approval
is extended for the time required for this test.
Regulation (2006:1049).
Obligation to inform about new information
section 29 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 who place an approved or registered biocidal product
on the market or that has a such a product approved or
registered, have in addition the obligation to immediately inform
The Swedish Chemicals Agency, if it will produce new information
If
1. composition of a biocidal product,
2. the origin of an active substance or composition,
3. development of resistance,
4. how the product is packaged, or
5. other circumstances that may be relevant for the further
the approval.
The Swedish Chemicals Agency must notify the
the notification obligation. Regulation (2008:258).
Review, amendment and revocation of authorisation
section 30 of the approval shall be reviewed, if there is evidence that
suggests that any condition referred to in section 9 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 31, an approval may be amended in respect of conditions for
use, if a change in the light of new scientific and
technical knowledge is justified from the point of view of human health or the environment.
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 9 are still fulfilled.
section 32 approval may be amended in respect of the
area of use. The extension of the application area should not
granted in breach of the conditions laid down in annex I or IA of
biocidal products directive applies to the active substance.
An amendment may be granted only if the conditions referred to
in section 9 are still fulfilled.
section 33 approval shall be revoked if
1. the conditions referred to in section 9 are no longer met;
2. false or misleading information has been provided
with respect to the facts on the basis of
authorisation, or
3. an active substance in the product has been removed from Annex I
or IA of the biocides directive.
An authorisation may also be cancelled if the applicant for
the approval request and state the reasons for it.
34 § in connection with that approval is revoked,
The Swedish Chemicals Agency decide that remaining stocks of
the product must be disposed, stored, be placed on the market and
be used during certain period of time. The time must be determined with reference to
what caused the suspension.
The decision should not mean that a product is placed on the
market or used in contravention of other provisions that are
applicable to the product.
The Swedish Chemicals Agency must notify the
the application of the first subparagraph.
repealed by regulation 35 (2014:429).
36 repealed by Regulation (2014:429).
repealed by regulation 37 (2014:429).
repealed by regulation 38 (2014:429).
repealed by regulation 39 (2014:429).
Packaging and product information
section 40 of the Swedish Chemicals Agency must notify the regulations on
packaging and labelling is needed with regard to the protection of
human health or the environment or is needed because of
the BPD. Regulation (2006:1049).
41 § biocidal products and active substances intended for use
in biocidal products may not be placed on the market unless they
packaged and labelled in accordance with the detailed rules referred to in
40 section. Regulation (2006:1049).
42 § The placing a biocidal product on the market or
relating to the transfer of such product shall inform the
buyers and users that the product must be used on a
safe way. The information must contain a call to
before using, always read the label that is on the
packaging and other product information.
The information shall be provided in such a way that it clearly
can be distinguished from other information.
43 repealed by Regulation (2006:1049).
Manufacture, storage and transportation in some cases
section 44 To a biocidal product is not approved under the provisions
in chapter 14. the environmental code and this regulation must not be added to the
basis to prevent that the product is manufactured, stored or
transported, if it is approved in another country in 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
carrying a biocidal product 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 (2008:258).
Use
45 section in the application of general rules of consideration in Chapter 2.
2-4 of the Environment Act shall in particular ensure that biocidal products
is used in a manner that is consistent with
1. the conditions for approval referred to in paragraph 9 of this
Regulation,
2. the conditions imposed under section 26, and
3. the labelling requirements referred to in section 40.
By combining physical, biological, chemical or
other methods, the use of biocidal products, as appropriate
way, be limited to the minimum necessary.
Regulation (2008:258).
Knowledge requirements, etc. in some cases
46 § a biocidal product falling within class 1 of section 25 of may
used only by someone who meets the specific knowledge requirements.
The Swedish Chemicals Agency may provide that an
biocidal product falling within class 2 of section 25 shall be used
only by satisfying specific skill requirements.
Regulations may require that the user should have
reached a certain age. Regulation (2008:258).
47 § the authority according to § 48 hears questions about permits
may provide details relating to the skills required
and if the age restrictions for use. Before a regulation
granted, the authority shall consult the Swedish Chemicals Agency.
Regulation (2008:258).
Permission for use
48 § a biocidal product falling within class 1 of section 25 of may
be used only with special permission. A State must
be for some time.
The issue of the permit are being assessed by the public health agency, when it
is the question about measures against vermin and pests according to Chapter 9. § 9
Environment Act, and by the Swedish work environment authority, when it is a matter of
other activities. Regulation (2013:897).
section 49 the authority under section 48 is trying 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 45, or
regulations referred to in section 46. Before a rule is announced
the authority shall consult the Swedish Chemicals Agency.
Exemption from prohibition
49 a of the question 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 there are
serious reasons. Before the environmental protection agency provides such a dispensation,
should really consult the Swedish Chemicals Agency, maritime and
the water authority, the State's agriculture and Forestry Board.
A waiver should be reconciled with the conditions required from a health
and environmental protection point of view. Regulation (2011:1199).
Temporary restrictions and prohibitions
50 § if there is reason to suspect that an approved
biocidal product or a product that the Swedish Chemicals Agency
is obliged to accept the product presents an unacceptable risk to
human health or the environment, the inspection
temporarily restrict or prohibit the use or
the sale of the product. If the inspection takes a
such a decision, the supervisory authority shall forthwith inform the
The European Commission and the other Member States within
The European Union.
In the case of registered low-risk biocidal products and
products inspection is required to register shall
the first subparagraph shall apply mutatis mutandis.
Regulation (2010:1191).
Supervision and fees
section 51 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 (2011:33).
Appeals, penalties and forfeiture
52 section in chapter 19. § 1 and 29. the environmental code includes provisions
on appeal, as well as penalties and forfeiture.
Regulation (2006:1049).
53 repealed by Regulation (2006:1049).
Competent authority
54 § the Swedish Chemicals Agency is the competent authority in accordance with
Article 81 of Regulation (EC) No 528/2012.
Regulation (2013:705).
Transitional provisions
2006:1049
This Regulation shall enter into force on 1 October 2006. Older
regulations still apply to orders delivered
before the entry into force.