The regulations cover equipment and protective systems intended for use in potentially explosive atmospheres which includes a range of products, namely those used on fixed offshore platforms, petrochemical plants, mines, and flour mills, amongst others.
What is an Explosive Atmosphere?
A potentially explosive atmosphere exists when a mixture of air gases, vapours, mists, or dusts combine in a way that can ignite under certain operating conditions
Obligations of Economic Operators
The regulations define specific requirements for all economic operators which are involved with the placing on the market of equipment and protective systems (products) namely, manufacturers, authorised representatives, importers and distributors. All the parts have an important role in making sure that the product is safe for use as described below.
The obligations of manufacturers are as follows: ensure that the products are designed and manufactured in accordance with the essential safety requirements set out in Regulations; draw up the technical documentation referred and carry out the relevant conformity assessment procedure; draw up an EU declaration of conformity and affix the CE marking, or where applicable to draw up a written attestation of conformity; ensure that the product is accompanied by a copy of the EU declaration of conformity or of the attestation of conformity, as appropriate; keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the product has been placed on the market; label products with a type, batch or serial number or other element allowing their identification; ensure that products, other than components, bear the specific marking of explosion protection and other markings as applicable; indicate on the product, their name, registered trade name or registered trade mark and the postal address at which they can be contacted; provide instructions and safety information in at least the Maltese or English language.
An authorised representative is appointed with a written mandate by the manufacturer which includes a list of tasks to be carried out namely conformity assessments, CE markings, EU declaration of conformity and provisions for holding the EU declaration of conformity, together with the technical documentation for a period of 10 years after the last product has been manufactured.
The obligations of importers are clearly defined in the regulations and to a large extent they are similar to those of the manufacturer. The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of products but has a key role to play in guaranteeing the compliance of the imported products.
The obligations of the distributors are namely to: have a clear indication of a products being non-compliant; ensure that products bear the CE marking, where applicable; products are accompanied by the EU declaration of conformity or the attestation of conformity and by instructions and safety information;
Conformity of Products with the Regulations
The regulation deal with the presumption of conformity of products through the voluntary application of European harmonized standards (published in the Official Journal of the European Union). Therefore, products which are in conformity with harmonized standards are presumed to be in conformity with the essential health and safety requirements of the regulations. The use of harmonized standards is commonly the preferred option for demonstrating compliance with the regulations.
Conformity assessment procedures
These procedures are defined in the regulations whereby the manufacturer or his authorised representative ensures and declares that their product complies with the regulations and its relevant essential health and safety requirements before it is placed on the market. A notified body is involved in the process which provide their professional and independent judgements to the manufactures or their authorised representatives to presume conformity with the regulations. Once the appropriate procedure has been carried out, the manufacturer or his authorised representative are responsible to affix the CE marking and to provide a written EU declaration of conformity with their product.
EU Declaration of Conformity
The EU declaration of conformity is a legal document drawn up by the manufacturer or his authorised representative declaring that the equipment or protective system fulfils the requirements of the regulations. The EU declaration of conformity must contain, where appropriate, the name and the identification number of the notified body, and the number of the EU-type examination certificate. Schedule X to the regulations states what the EU declaration of conformity must contain as a minimum.
The ‘CE’ marking is mandatory and must be affixed to the product or its data plate by the manufacturer or his authorised representative before being placing on the market or put into service. By the CE marking, the manufacturer or his authorised representative is declaring that the product conforms with the requirements of the regulations and that the product has undergone the appropriate conformity assessment procedures. The CE marking is excluded for components; however, these must be delivered with a written attestation of conformity stating their conformity with the regulations, characteristics and their incorporation into equipment or protective systems.
Depending on the conformity assessment procedure applied (either design phase or production phase or both phases), the CE marking shall be accompanied by the identification number of notified body in case the body is involved in the production control phase. Further to the CE marking the following specific markings shall be affixed:
Explosion protection (‘epsilon-x’, or ‘the hexagon’)
Symbol of the group and category
Letter ‘G’ (concerning explosive atmospheres caused by gases, vapours or mists) and/or ‘D’ (concerning explosive atmospheres caused by dust).
All products must be marked also with the registered name and address of the manufacturer, designation of series or type, serial number (if any) and the year of construction
Written Attestation of Conformity of components
In addition to the declaration of conformity of components, the written attestation of conformity must be delivered with the components and must state the characteristics of the components and how the components are to be incorporated into equipment or protective systems.