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Application Form for the Authorisation of a Plant Protection Product

FORM DETAILS

Applications will not be considered valid unless the application form is duly completed and all correct documents and correct labels have been submitted with this form. Payment has to be effected within 3 days from the submission of this form for the application to be considered valid. It is recommended that proof of payment of the applicable fees is submitted via the upload section available hereunder, otherwise the application will not be processed until payment is performed.

APPLICANT DETAILS (PERMANENT COMMUNITY ADDRESS)

Are you a returning user?

A 'returning user' is one who has at least filled in this form once, from the 3rd of August 2020 onwards. If any personal or company details have changed from when you last submitted this form, the you are kindly asked to click 'No'. By clicking 'Yes', you are declaring that you have already provided your personal details in this form, and will therefore be asked for the email address only.

If you are unsure whether you are a returning user or not, you may either click 'No' or else contact the MCCAA for assistance.

Full name

Address

Email address

Please check the format of your answer.

Please ensure that the email address is correct as it will be used for acknowledgement purposes and also to get in touch with you.

Telephone no.

Only numbers may be entered in this field.

Mobile no.

Only numbers may be entered in this field.

Contact person

DETAILS OF REPRESENTATIVE IN MALTA (IF APPLICABLE)

Full name

Address

Email address

Please check the format of your answer.

Telephone no.

Only numbers may be entered in this field.

Mobile no.

Only numbers may be entered in this field.

Contact person

CERTIFICATE

EU Member States where the product is authorised

Please fill in at least one answer

	Member State	Registration number	Date	Product name	Expiry date
1	Member State	Registration number	Date	Product name	Expiry date
2	Member State	Registration number	Date	Product name	Expiry date

ACTIVE INGREDIENT 1

Content & tolerance limits of active ingredient in % [w/w, g/l] in the technical product

	Active ingredient	CAS number	Content (% technical)	Content (% pure)	Tolerance limit % (w/w, g/l)
1	Active ingredient	CAS number	Content (% technical)	Content (% pure)	Tolerance limit % (w/w, g/l)

Active ingredient classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
1	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

Is the ownership of data on the active ingredient different from the applicant details?

Choose one of the following answers

Yes
No, because the applicant and ownership of data are identical

If 'yes' please fill in the details of the owner who gave you the letter of access

Company name
Address
Email address
Contact no.
Contact person

ACTIVE INGREDIENT 2

Content & tolerance limitsof active ingredient in % [w/w, g/l] in the technical product

	Active ingredient	CAS number	Content (% technical)	Content (% pure)	Tolerance limit % (w/w, g/l)
2	Active ingredient	CAS number	Content (% technical)	Content (% pure)	Tolerance limit % (w/w, g/l)

Active ingredient classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
2	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

Is the ownership of data on the active ingredient different from the applicant details?

Choose one of the following answers

Yes
No, because the applicant and ownership of data are identical
No answer

If 'yes' please fill in the details of the owner who gave you the letter of access

Company name
Address
Email address
Contact no.
Contact person

ACTIVE INGREDIENT 3

Content & tolerance limitsof active ingredient in % [w/w, g/l] in the technical product

	Active ingredient	CAS number	Content (% technical)	Content (% pure)	Tolerance limit % (w/w/, g/l)
3	Active ingredient	CAS number	Content (% technical)	Content (% pure)	Tolerance limit % (w/w/, g/l)

Active ingredient classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
3	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

Is the ownership of data on the active ingredient different from the applicant details?

Choose one of the following answers

Yes
No, because the applicant and ownership of data are identical
No answer

If 'yes' please fill in the details of the owner who gave you the letter of access

Company name
Address
Email address
Contact no.
Contact person

CO-FORMULANT 1

Co-Formulant information

	Co-Formulant	CAS number	Content
1	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
1	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 2

Co-Formulant information

	Co-Formulant	CAS number	Content
2	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
2	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 3

Co-Formulant information

	Co-Formulant	CAS number	Content
3	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
3	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 4

Co-Formulant information

	Co-Formulant	CAS number	Content
4	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
4	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 5

Co-Formulant information

	Co-Formulant	CAS number	Content
5	Co-Formulant	CAS number	Content

Co-Formulant classifcation

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
5	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 6

Co-Formulant information

	Co-Formulant	CAS number	Content
6	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
6	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 7

Co-Formulant information

	Co-Formulant	CAS number	Content
6	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
7	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 8

Co-Formulant information

	Co-Formulant	CAS number	Content
8	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
8	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 9

Co-Formulant information

	Co-Formulant	CAS number	Content
9	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
9	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

CO-FORMULANT 10

Co-Formulant information

	Co-Formulant	CAS number	Content
10	Co-Formulant	CAS number	Content

Co-Formulant classification

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
10	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

PLANT PROTECTION PRODUCT

Current classification of product

	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)
1	Hazard pictogram code and signal word (Click here to view pictograms)	Hazard statement (H-Numbers)	Precautionary statement (P-Numbers)

Results of analysis of product (insert figures of results of analysis)

	Results
DL 50 oral rat (mg/kg)	Results
DL 50 dermal rat (mg/kg)	Results
CL 50 inhalation rat (mg/l/4h)	Results
Eye irritation rabbit	Results
Dermal irritation rabbit	Results
Sensitisation	Results
Fish (CL 50 in mg/l)	Results
Daphnia (EC 50 in mg/l)	Results
Algae (LC 50 in mg/l)	Results
Other studies	Results
Notes	Results

Impurities

	Name	CAS number	%
1	Name	CAS number	%
2	Name	CAS number	%
3	Name	CAS number	%
4	Name	CAS number	%
5	Name	CAS number	%

REGISTRATION REPORT

A final Registration Report (Parts A+B+C) supplying the information necessary as required in Article 33(3) of Regulation EC 1107/2009 is to be attached with this form

Choose one of the following answers

Yes
No, it is not available yet and a formal letter is attached with this form

Note: If 'no' is selected, applicant must supply a formal letter stating that the Registration Report in conformity with Regulation 1107/2009 will be supplied as soon as available.

PACKAGING

Retail packaging size in Malta

Please fill in at least one answer

	Quantity	Unit (g/kg/ml/l)
1	Quantity	Unit (g/kg/ml/l)
2	Quantity	Unit (g/kg/ml/l)
3	Quantity	Unit (g/kg/ml/l)
4	Quantity	Unit (g/kg/ml/l)

REQUESTED DOCUMENTATION

Please ensure that all documentation below is attached to this form:

A free sales certificate / marketing authorisation from an EU competent authority;
Formal statement that the plant protection product is identical to that authorised by the reference Member State;
Letter of access of each active ingredient (in the event that ownership of data on active ingredient is different than applicant data);
Signed document with detailed chemical composition of the PPP;
List of studies for Data Protection in Malta. Please provide the list in '.xls' format as presented in Annex I;
SDS for the product in accordance with Regulation 1272/2008/EC as applicable;
SDS for each active substance and co-formulant in accordance with Regulation 1272/2008/EC as applicable;
A final Registration Report (Parts A+B+C) supplying the information necessary as required in Article 33(3) of Regulation (EC) 1107/2009 or a formal letter stating that the registration report will be supplied as soon as avialable;
Original labels;
Official translation in English (if original is not in English);
Official translation in Maltese (note that if Maltese alphabet is not used, the label [and application] will not be valid).

Kindly attach any relevant documents (you may opt to compress all files into .a rar file not larger than 10MB)

Please upload between 1 and 10 files

Upload files

Use this option to:

- attach any relevant supporting information as noted hereabove in the documentation checklist.
- upload proof of payment.

PAYMENT DETAILS

Payment of:

€500 for new authorisation
€350 for new authorisation if active substance is approved as low-risk in line with Regulation 1107/2009
€200 for renewal of authorisation

Payment has to be effected within 3 days from submission of application

Payment method

Choose one of the following answers

Bank transfer
Cheque (payable to MCCAA)

Bank Account Details

Bank name: Bank of Valletta

IBAN number: MT14VALL22013000000040019986609

Swift code: VALLMTMT

DECLARATIONS

Content Declaration

Check all that apply

I, hereby declare that the details furnished in this application are true and correct to the best of my knowledge and belief and I undertake to inform the Malta Competition and Consumer Affairs Authority of any changes therein, immediately. In case any of the above information is found to be false, untrue, misleading or misrepresenting, I am aware that I may be held liable for it.

Data Protection Declaration

Check all that apply

The Malta Competition and Consumer Affairs Authority ("the Controller") will process your personal data in accordance with the relevant provisions of the General Data Protection Regulation (GDPR), the Data Protection Act (Chapter 586 of the Laws of Malta) and other regulations made thereunder. The Controller will process your personal data for licensing and administrative purposes and to comply with its legal obligations. For further information on how your personal data will be processed refer to the Controllers's privacy policy.
I, the data subject, hereby consent to having the Malta Competition and Consumer Affairs Authority collect and process my personal information from this application.

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