MIP-0007-E
Application - Plant protection
products containing nematodes,
insects or arachnids
Application
The numbers in the drop down list refers to the numbers in the price list with application fees for plant protection products.
No
Information
1
Type of application procedure
<Choose alternative>
Product information
If the product contains GMO, please contact the Swedish Chemicals Agency (KemI) for more information.
If the product contains micro organisms, do not use this application form. There are other forms (MIP-0012-E, MIP-0016-E, MIP0017-E, MIP-0019-E and MIP-0023-E) corresponding to the application procedures.
No
Information
2
Name of the product
3
Formulant and appearance
4
Wetness, forming aerosols, suspension- or emulsion persistence
5
Development stage at sale
6
Lasting time
7
Production method
Authorisation no. (if the product is, or has
been, authorised in Sweden)
Annex
Signature1
8
Applying company
Date
Signature
Printed name
Payment3
The Swedish Chemicals Agency makes a decision on the
application fee and sends the decision together with an invoice.
The invoice states the amount to be paid and how to pay it.
A list of application fees is available at KemI’s website. There is
also a tool that helps you estimate the fee.
Mall-id: MIP-0007-E, 3
/26/2013
Send the application2 to:
Swedish Chemicals Agency
Box 2
SE-172 13 Sundbyberg, Sweden
or to:
kemi@kemi.se
If the signature is done by someone other than the applying company, a power of attorney confirming the right to sign the application
on behalf of the applicant should be submitted.
2 The first page of this application form, and Letter of Access, should be submitted as signed originals. All other documents, including
the remainder of the application form, can be delivered on CD or in another digital form.
3 According to Ordinance (2013:63) on Pesticide Fees
1
Swedish Chemicals Agency
Mailing address
Visit & delivery
Invoicing address
Phone & fax
Internet
VAT No
Box 2
SE-172 13 Sundbyberg
Sweden
Esplanaden 3A
SE-172 67 Sundbyberg
Sweden
FE 124
SE-838 80 Hackås
Sweden
Phone +46 8 519 41 100
Fax +46 8 735 76 98
www.kemi.se
kemi@kemi.se
SE202100388001
MIP-0007-E
Application - Plant protection
products containing nematodes,
insects or arachnids
Swedish Chemicals Agency
Applicant
Current or future authorisation holder, i.e. the party responsible for initial placing of the product on the Swedish market.
No
Information
9
Company name
Company´s registration no. (see no. 10 below)
Address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
10
A company/corporation certificate should be submitted by all companies that have no previously authorised plant protection
product in Sweden. Company/corporation certificates can also be required if there have been changes since the last product
authorisation or if more than 6 months has elapsed since the last application was filed.
Applying company´s/corporation´s certificate is attached
Temporary representative4 (if applicable)
Representing the authorisation holder (i.e. the applicant in no. 9 above) only during the application procedure
No
Information
11
Company name
Company´s registration no.
Address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
12
A representative should prove the appointed level of representation by the applicant, in original.
Power of attorney as temporary representative is attached
Permanent representative (if applicable)
Representing the authorisation holder (i.e. the applicant in point 9 above) during the authorisation period (“ombud” in Swedish)
No
Information
13
Company name
Company´s registration no. (see no. 14 below)
Mailing address
Telephone no. (incl. country code)
Postal code and town
Contact person
Country
E-mail address
14
A company/corporation certificate should be submitted by all companies that have no previously authorised plant protection
product in Sweden. Company/corporation certificates can also be required if there have been changes since the last product
authorisation or if more than 6 months has elapsed since the last application was filed.
15
A representative should prove the appointed level of representation by the applicant in original
Representing company´s/corporation´s certificate is attached
Power of attorney as permanent representative is attached
The applicant is fully responsible for the placing of a plant protection product on the Swedish market. The representative cannot hold
the authorisation.
4
2 (6)
MIP-0007-E
Application - Plant protection
products containing nematodes,
insects or arachnids
Swedish Chemicals Agency
Invoicing address for application fee
No.
Information
16
Application fee will be paid by
Authorisation holder
Temporary representative
Permanent representative
Invoicing address
Contact person (name/e-mail/tel)
Postal code and town
Country
If application for amendment of product authorisation
No
Information
17
Describe the amendment (composition, area of use etc.)
Annex
If application for derogation
No
Information
18
Reason (describe why a derogation is needed)
Annex
19
Area of use (describe which crop the product will be used in, and against what pest)
20
Additional information
Organism no. 1
No
Information
Annex
21:1
Name, taxonomy and art description
22:1
Function and quantity
23:1
Biological characteristics and ecology
24:1
History of macro organism and it´s area of use
25:1
Natural occurrence, establishment, environmental requirements (can handle temperature under 0°C in 24 h) and
ability to spread
26:1
Life cycle
27:1
Host/prey spectrum
28:1
Genetical stability
29:1
Origin
30:1
Mode of action
31:1
Indirect and direct effects of non target organism
3 (6)
MIP-0007-E
Application - Plant protection
products containing nematodes,
insects or arachnids
Swedish Chemicals Agency
No
Information
32:1
Cultivation method/breeding method
Annex
Organism no. 2 (if applicable)
No
Information
21:2
Name, taxonomy and art description
Annex
22:2
Function and quantity
23:2
Biological characteristics and ecology
24:2
History of macro organism and it´s area of use
25:2
Natural occurrence, establishment, environmental requirements (can handle temperature under 0°C in 24 h) and
ability to spread
26:2
Life cycle
27:2
Host/prey spectrum
28:2
Genetical stability
29:2
Origin
30:2
Mode of action
31:2
Indirect and direct effects of non target organism
32:2
Cultivation method/breeding method
Organism no. 3 (if applicable)
(If more than three active organisms are included in the product, please fill in complementary information in a separate document.)
No
Information
21:3
Name, taxonomy and art description
Annex
22:3
Function and quantity
23:3
Biological characteristics and ecology
24:3
History of macro organism and it´s area of use
25:3
Natural occurrence, establishment, environmental requirements (can handle temperature under 0°C in 24 h) and
ability to spread
26:3
Life cycle
27:3
Host/prey spectrum
28:3
Genetical stability
4 (6)
MIP-0007-E
Application - Plant protection
products containing nematodes,
insects or arachnids
Swedish Chemicals Agency
No
Information
29:3
Origin
Annex
30:3
Mode of action
31:3
Indirect and direct effects of non target organism
32:3
Cultivation method/breeding method
Area of use
No
Information
33
Area of use
34
Target organism (taxonomy, biology, life cycle)
35
Dose
36
Efficacy
37
Application technique
38
Side effects
39
Cleaning technique for equipment
40
Risk information and safety phrases
41
Measurements at wrong way of handling
42
Destruction method
43
Authorisation/use in other Member States
44
Combined use
Outdoors
Annex
Green houses
Package
No
Information
45
Label
46
Packaging
Annex
5 (6)
MIP-0007-E
Application - Plant protection
products containing nematodes,
insects or arachnids
Swedish Chemicals Agency
Health effects
No
Information
47
Skin irritation
48
Eye irritation
49
Skin sensitisation
50
Other studies
51
Information about the non-active ingredients in the plant protection product
No
Ingredient
Annex
Function
Quantity
Annex
1)
2)
3)
4)
5)
52
Case reports, clinical and epidemiological studies
53
Exposure levels
Conclusion of health and environmental risks
No
Information
Annex
54
Conclusion of health risk assessment (exposure and effects on humans)
55
Conclusion of environmental risk assessment (exposure and establishment in the environment and influence on
biological variety)
Other information
No
Information
56
Ongoing research projects
57
Other information
Annex
Access to documentation
Active organism or product studies
Owner of
documentation
* For more information, please see our website www.kemi.se
6 (6)
Documentation
without data
protection
Letter of Access*
(the right to use other
part´s documentation)
Annex