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Regulation (2000:338) On Biocidal Products Containing Nematodes, Insects Or Arachnids

Original Language Title: Förordning (2000:338) om biocidprodukter som innehåller nematoder, insekter eller spindeldjur

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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.