User Guidelines – Internal Market Emergency *Click to download*
The proposed provisions transpose Directive (EU) 2024/2839 of the European Parliament and of the Council of 23 October 2024 amending Directives 1999/2/EC, 2000/14/EC, 2011/24/EU and 2014/53/EU as regards certain reporting requirements in the fields of food and food ingredients, outdoor noise, patients’ rights, and radio equipment.
Also, the proposed provisions transpose Directive (EU) 2024/2749 of the European Parliament and of the Council of 9 October 2024 amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regards emergency procedures for the conformity assessment, presumption of conformity, adoption of common specifications and market surveillance due to an internal market emergency.
The amended Directives are transposed into national law by means of the following legislation:
1. Simple Pressure Vessels Regulations (S.L. 427.01)
2. Noise Emission in the Environment by Equipment for Use Outdoors (S.L. 427.19);
3. Pressure Equipment Regulations (S.L. 427.29);
4. Transportable Pressure Equipment Regulations (S.L. 427.30);
5. Low Voltage Electrical Equipment Regulations (S.L. 427.34);
6. Electromagnetic Compatibility Regulations (S.L. 427.35);
7. Machinery Regulations (S.L.427.36);
8. Lifts Regulations (S.L. 427.37);
9. Equipment and Protective Systems intended for Use in Potentially Explosive Atmospheres Regulations (S.L. 427.39); and
10. Radio Equipment Regulations (S.L. 427.41).
The proposed Legal Notice amends the aforementioned legislation to align national law with the requirements of Directive (EU) 2024/2749, thereby allowing national competent authorities to derogate from the conformity assessment procedures to mitigate the potential impact of internal market disruptions during a crisis and ensure that, when the internal market emergency mode is activated, harmonised crisis-relevant goods can be placed on the market without delay.
For the purpose of the proposed legal notice only the amendments to Directives 2000/14/EC and 2014/53/EU are of relevance since only these relate to products which are regulated by means of legislation falling under the Product Safety Act. These amendments concern noise emissions from equipment intended for outdoor use and radio equipment, which are transposed into national law by means of the following legislation:
1. The Noise Emission in the Environment by Equipment for Use Outdoors Regulations (S.L. 427.19); and
2. The Radio Equipment Regulations (S.L. 427.41).
As regards the Radio Equipment Regulations, the amendments required to transpose Directive (EU) 2024/2839 have already been enacted through Legal Notice 202 of 2025.
With respect to equipment for use outdoors, the proposed legal notice removes the obligation on manufacturers, or their authorised representatives, to submit to the competent authority a copy of the EC Declaration of Conformity for each type of equipment they intend to place or put into service on the EU internal market. This amendment reduces administrative burdens on both businesses and competent authorities and reflects the fact that consumers can obtain the necessary information on noise emissions directly from the equipment itself.
Thus, the above-mentioned subsidiary legislation falling under the Product Safety Act (Cap. 427 of the Laws of Malta) shall be amended accordingly on a national level by means of these proposed regulations.
These user-guidelines are being published in accordance with article 3 of the Small Business Act (Cap. 512).
