A DoP is required when a product is covered by a harmonised standard or has a European Technical Assessment.
A DoP is required when a product is covered by a harmonised standard or has a European Technical Assessment.
From January 2027, a Declaration of Performance and Conformity (DoPC) will replace the DoP for harmonised products.
No. Only products covered by harmonised rules and supported by a DoP (or DoPC) may carry the CE mark.
Manufacturers must ensure documentation, issue a DoP/DoPC, affix CE marking, maintain traceability, and cooperate with authorities.
Importers must verify compliance, ensure CE marking and documentation, include their details on the product, and cooperate with authorities.
Distributors must verify CE marking, ensure documentation is available, and ensure proper storage and handling.
It refers to the first supply of a product in the EU for distribution or use.
No. For harmonised products, only the CE mark may be used to declare performance.
These are systems that define how product performance is assessed and verified.
Yes. SMEs may use simplified documentation methods in certain cases, as allowed under EU rules.
A biocidal product contains active substances that control harmful organisms, such as bacteria or pests. It is usually identified by claims like ‘disinfectant’, ‘kills bacteria’, or ‘insect repellent’.
Common examples include disinfectants, hand sanitisers, insecticides, and repellents. If unsure, you may submit the product label and Safety Data Sheet to MCCAA for guidance.
Yes. Biocidal products must be approved by MCCAA before being placed on the Maltese market, even if already authorised in another EU country.
The process depends on the active substances in the product. Some applications are handled locally, while others must be submitted by the manufacturer at EU level.
Products with active substances still under EU review may be registered through MCCAA’s notification process, supported by required documentation.
It is typically completed within a few weeks. The fee is €100 for a new application and €50 for renewal.
Products with approved active substances must be authorised via ECHA’s R4BP system, usually by the manufacturer.
Timeframes vary from months to longer, depending on the case. Fees start from €500.
Labels must include key safety and usage information, such as active substances, instructions for use, and supplier details, in English and/or Maltese.
MCCAA publishes an official list of registered biocidal products on its website.
You may report it to MCCAA, providing details such as the product name, photos, and place of sale.
Regulators must be suitable for LPG, as domestic gas in Malta is a butane-propane mixture.
Regulators must include key information such as manufacturer details, LPG marking, pressure, flow rate, connection type, and EN 16129 compliance.
Yes. Regulators must be marked ‘LPG’. Markings such as ‘butane/propane’ are not permitted.
Yes. Operating and installation instructions must be included in Maltese and/or English, indicating the product’s lifetime.
It is a document confirming that a vehicle, system, component, or unit meets the required approval standards.
It verifies that a product complies with EU or UNECE requirements before it can be placed on the market.
A vehicle approved in one EU country can be marketed across the EU without repeating tests.
It is the national authority responsible for issuing approvals and ensuring manufacturers meet legal requirements.
A designated body that carries out testing, inspections, or assessments required for type approval.
