Application Forms

Application Form for the Notification of a Biocide

What are biocidal products?

Biocidal products are any substance or mixture:

• in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances
• generated from substances or mixtures which do not themselves fall under the above, to be used

with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

Treated articles that have a primary biocidal function are also considered biocidal products.

Biocidal products are regulated in the EU by the Biocidal Products Regulation, the BPR (Regulation (EU) 528/2012), which repealed Directive 98/8/EC (the Biocidal Products Directive).and is implemented in national legislation through subsidiary Legislation SL 430.09 entitled ‘Biocidal Products(Implementation of Regulation (EU) No 528/2012) Regulations’

For questions, the biocidal product helpdesk at MCCAA can be contacted through e-mail at biocides@mccaa.org.mt.

Legislation

Subsidiary Legislation 430.09: Biocidal Products (Implementation of Regulation (EU) No. 528/2012)

Regulation (EU) No. 528/2012: The Biocidal Products Regulation

Regulation (EU) No. 1062/2014 on the existing active substances review programme

Relevant Documentation

Article 95 Self-Declaration form templates (published by the European Commission)

Database of Registered Biocidal Products in Malta (last updated 17th April 2023)

Sanitisers effective against viruses according to WHO and ECDC guidelines or testing for viruses (last updated 17th April 2023)

Placing on the Market of Biocidal Products

The placing on the Maltese market of biocidal products must be approved by the 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 the MCCAA is necessary before placing the product on the market. Notifications are valid for 3 years and cost 100 euro (50 euro for a renewal of a notification). For a notification application to be successful, the 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.

In case of imported products that contain active substances still under review and are already included in the MCCAA’s publicly available database of Registered Biocidal Products in Malta, then biocidal product might be eligible for Parallel Trade Notification.

While less supporting documentation is required for this procedure, acceptance is subject to applicant providing sufficient proof that the biocidal product being made available on the market in Malta is identical to the product already notified in Malta. Parallel Trade Notifications are valid for up to 2 years and cost €100. 

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. 

Further Information

European Commission Biocidal Products portal
European Chemicals Agency (ECHA)’s Biocidal Products portal
Article 95
Article 95 list
Guidance on the compilation of safety data sheets 
CLP: Guidance on Labelling and packaging in accordance with Regulation (EC) No 1272/2008

For further information or in case of queries kindly contact pesticides.regulations@mccaa.org.mt