Part 6B: Compulsory documentation
In case of an application for an Article 34:
- An application overview (cover letter), addressed to the MCCAA.
- Draft Registration Report (Part A, Part B0 and Part C).
- Draft product label in English and Maltese language (Note: The product label in Maltese language can be submitted at finalisation stages).
- A Safety Data Sheet (SDS) for the product, each active substance and co-formulant in compliance with Commission Regulation (EU) 2020/878 amending Regulation (EC) No. 1907/2006 and classification in accordance with Regulation (EC) No 1272/2008. The SDSs shall not be older than 1 year from the submission of the application form.
- Full (100%) chemical composition for each co-formulant, including a signed statement from the suppliers declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the co-formulants. If this is considered business confidential information for the suppliers, the required information shall be provided directly to the MCCAA on [email protected].
- A signed statement from the applicant declaring that no unacceptable co-formulants according to Regulation (EU) 2021/383 are included in the product/formulation.
- Letter of Access and Supply (if applicable) for technical equivalence sources.
Note: Other documentation may be requested to be submitted on case-by-case basis and/or as deemed necessary for the examination of the dossier.