Regulatory Affairs Directorate
Market Surveillance Directorate
Placing on the market
The placing on the Maltese market of biocidal products must be approved by MCCAA. The procedure used by a placer of biocidal products on the market varies depending on the active substance (a substance that has an action on or against harmful organisms) of the biocidal product.
Active substances are part of a Review Programme at the Union level. They can be either non-approved, approved or under review. Non-approved active substances cannot be placed on the European market. The status of an active substance can be determined by searching the Biocidal Active Substances database maintained by ECHA at Biocidal Active Substances - ECHA.
For products containing under review substances, a notification to MCCAA is necessary before placing the product on the market. Notifications are valid for 2 years and cost 25 euro (10 euro for a renewal of a notification). For a notification application to be successful, MCCAA requires the following documents for each product:
- ·Filled in and signed application form
- ·REACH and CLP compliant Safety data sheet (SDS) of the product (Safety Data Sheets - ECHA)
- ·REACH and CLP compliant SDSs of the individual hazardous substances found in section 3 of the product’s SDS
- ·Scanned or PDF copy of the product label (compliant with CLP labelling requirements: CLP Labelling)
- ·Evidence that the active substance in the product originates from an approved supplier found on the Article 95 List. This evidence may be in the form of a recent invoice, a letter from the supplier or a self-declaration form. The Article 95 list is a list of approved suppliers of biocidal products or active substances maintained by ECHA. As of 1 September 2015, all biocidal products being made available on the market must contain an active substance that ultimately originates from one of the suppliers on the list.
For products containing approved substances, an application must be submitted through the Register for Biocidal Products maintained by the European Chemicals Agency (ECHA). If you are a distributor of biocidal products containing active substances which are all approved, your supplier must be the authorisation holder of an active authorisation in R4BP3, submitted through the mutual recognition procedure or otherwise. The supplier should then submit a letter (via e-mail, post or otherwise) to MCCAA stating that they authorise the distributor to sell their product in Malta. More information can be found on R4BP 3 - Register for Biocidal Products - ECHA , the official website of ECHA.