Application Form for the Change of Labelling of Plant Protection Products
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Application Form for the Change of Labelling of Plant Protection Products

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 fess is submitted via the upload section available hereunder, otherwise the application will not be processed until payment is performed.

For more information and guidance on how to fill this form, please click here.

GENERAL INFORMATION
(This question is mandatory)
Authorised trade name
Proposed trade name
DETAILS OF CURRENT AUTHORISATION HOLDER
(This question is mandatory)
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.

(This question is mandatory)
Full name
(This question is mandatory)
Address
(This question is mandatory)
Email address
Please ensure that the email address is correct as it will be used for acknowledgement purposes and also to get in touch with you.
(This question is mandatory)
Telephone no.
Mobile no.
(This question is mandatory)
Contact person
DETAILS OF CURRENT MALTESE REPRESENTATIVE (IF APPLICABLE)
Full name
Address
Email address
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.
Mobile no.
Contact person
DETAILS OF NEW AUTHORISATION HOLDER (IF APPLICABLE)
Full name
Address
Email address
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.
Mobile no.
Contact person
DETAILS OF NEW REPRESENTATIVE IN MALTA (IF APPLICABLE)
Full name
Address
Email address
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.
Mobile no.
Contact person
CHEMICAL COMPOSITION OF CURRENT PRODUCT
Current authorised chemical composition of PPP - active ingredient
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Current authorised chemical composition of PPP - co-formulant
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NEW CHEMICAL COMPOSITION OF THE PRODUCT
New chemical composition of PPP - active ingredient
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New chemical composition of PPP - co-formulant
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FINAL CLASSIFICATION AND LABELLING - EXISTING CLASSIFICATION
Existing classification and labelling under Regulation 1272/2008/EC
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FINAL CLASSIFICATION AND LABELLING - PROPOSED CLASSIFICATION
Proposed classification (please fill in as appropriate)
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Supplementary phrases (as required by Regulation (EU) 547/2011, implementing Regulation (EU) 1107/2009)
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Underlying principle for the newly proposed classification & labelling of PPP - Classification of PPP (Hazard class and category)
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Underlying principle for the newly proposed classification & labelling of PPP - Classification of PPP (Hazard statement and category)
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Underlying principle for the newly proposed classification & labelling of PPP - Labelling of PPP (Pictograms)
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Underlying principle for the newly proposed classification & labelling of PPP - Labelling of PPP (Signal word/s)
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Underlying principle for the newly proposed classification & labelling of PPP - Labelling of PPP (Hazard statement/s [number])
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Underlying principle for the newly proposed classification & labelling of PPP - Labelling of PPP (Precautionary statement/s [number])
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Underlying principle for the newly proposed classification & labelling of PPP - Labelling of PPP (Special risks [number])
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Underlying principle for the newly proposed classification & labelling of PPP - Labelling of PPP (Supplemental hazard and information [number])
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Underlying principle for the newly proposed classification & labelling of PPP - Labelling of PPP (Notes [letter / number])

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CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES
Classification related endpoints - physical hazards (please fill in as appropriate)
Explosives
Flammable gases
Flammable aerosols
Oxidising gases
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances & mixtures
Pyrophoric liquids
Pyrophoric solids
Self-heating substances & mixtures
Substances & mixtures which in contact with water, emit flammable gases
Oxidising liquids
Oxidising solids
Organic peroxides
Corrosive to metals
Classification related endpoints - health hazards (please fill in as appropriate)
Acute toxicity DL 50 oral rat (mg/kg)
Acute toxicity DL 50 dermal rat (mg/kg)
Acute toxicity LC 50 inhalation rat (mg/l/4h)
Skin corrosion / irritation - Dermal irritation rabbit
Serious eye damage / irritation - Eye irritation rabbit
Respiratory sensitisation
Skin sensitisation
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ systemic toxicity: single exposure
Specific target organ systemic toxicity: repeated exposure
Aspiration hazard
Classification related endpoints - environmental hazards (please fill in as appropriate)
Acute (short term) aquatic hazard - 96hr LC 50 (for fish) and / or 48hr EC 50 (for crustacea)
Acute (short term) aquatic hazard - 72 or 96hr ErC 50 (for algae or other aquatic plants)
Chronic (long term) aquatic hazard - 96hr LC 50 (for fish) and / or 48hr EC 50 (for crustacea)
Chronic (long term) aquatic hazard - 72 or 96hr ErC 50 (for algae or other aquatic plants)
CHANGES IN AUTHORISATION CONDITIONS OF LABEL
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CHANGES IN PACKAGING
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CHANGES IN MANUFACTURING SITES
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REQUESTED DOCUMENTATION

Please ensure that all documentation below, unless stated otherwise, is attached to this form:

  • 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);
  • If applicable, a list of studies for Data Protection in Malta should be provided in '.xls' format as presented in Annex II;
  • 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.

In case of changes in the chemical composition of the product:

  • Signed document with revised chemical composition of product plant protection (it is required that the signed document is submitted by post);
  • SDSs of revised product in accordance with Regulation 1272/2008/EC;
  • Updated registration report.

In case of changes in final classification and labelling:

  • Updated SDSs in accordance with  Regulation 1272/2008/EC, of active ingredient and / or co-formulant which resulted in the change of classification;
  • Updated registration report.

In case of changes in changes in authorisation conditions of label, changes in packaging, and / or changes in manufacturing sites:

  • Updated registration report.

Note: SDSs for active ingredient, co-formulants and final product should be submitted if any of those originally submitted have been updated.

If authorisation of the product is through Mutual Recognition, and authorisation document by reference Member State authorising the change is required.

Kindly attach any relevant documents (you may opt to compress all files into .a rar file not larger than 10MB)
 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 €100 to be effected within 3 days from submission of application
(This question is mandatory)
Payment method

Bank Account Details

Bank name: Bank of Valletta

IBAN number: MT14VALL22013000000040019986609

Swift code: VALLMTMT

DECLARATIONS
(This question is mandatory)
Content Declaration
(This question is mandatory)
Data Protection Declaration
 

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