Subsidiary Legislation 427.57, Restriction of Use of Hazardous Substances in Electrical and Electronic Equipment Regulations, transposes Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

Scope 

The Directive and regulations on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) aim to prevent hazardous substances from entering the production process and thereby keep them out of the waste stream; whilst protecting human health and the environment and promoting the environmentally sound recovery and disposal of waste electrical and electronic equipment (WEEE).

Applicability 

The Directive and regulations apply to electrical and electronic equipment as per the below categories; some examples are included. They also apply to all wires, cables and associated connectors, both internal and external, and to all spare parts. Exclusions are given to certain special cases, while exemptions are provided on temporary basis depending on the scientific and technical progress of specific applications.

Category 1: Large household appliances - refrigerators, washers, stoves, air conditioners

Category 2: Small household appliances - vacuum cleaners, hair dryers, coffee makers, irons

Category 3: IT and telecommunications equipment - computers, printers, copiers, phones, satellite TV, cell tower equipment, antennas

Category 4: Consumer equipment - TVs, DVD players, stereos, video cameras

Category 5: Lighting equipment - lamps, lighting fixtures, light bulbs

Category 6: Electrical and electronic tools - drills, saws, nail guns, sprayers, lathes, trimmers, blowers

Category 7: Toys, leisure and sports equipment - videogames, treadmills, talking dolls

Category 8: Medical devices including in vitro diagnostic medical devices

Category 9: Monitoring and control instruments including industrial monitoring and control instruments. - thermostats, smoke detectors, fire alarms

Category 10: Automatic dispensers - vending machines, ATM machines

Category 11: Catch-all - all electrical and electronic equipment not covered by any of the categories above.

The current ten hazardous substances that are being restricted, are:

• 4 heavy metals: lead, mercury, cadmium and hexavalent chromium;
• 2 flame retardants: polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE); and
• 4 phthalates: bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

Obligations of manufacturers

The obligations of manufacturers of electrical and electronic equipment include:

1. Before placing electrical and electronic equipment on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the requirements and that they have had the conformity assessment procedure carried out and the technical documentation drawn up.
2. Once this has been done, a manufacturer must draw up the EU Declaration of Conformity and affix the CE marking to the product.
3. Manufacturers must keep the technical documentation and the EU Declaration of Conformity for 10 years after the electrical and electronic equipment has been placed on the market.
4. Manufacturers must label electrical and electronic equipment with their name, registered trade name or registered trademark and postal address; and the type, batch or serial number (or other identification).
5. The manufacturers must put procedures in place to ensure that series production remains in conformity with the regulations.
6. The manufacturers must keep a register of non-conforming electrical and electronic equipment and product recalls, while keeping distributors informed.
7. They must take action where they have reason to believe that the electrical and electronic equipment that they have placed on the market is not in conformity with the regulations and they must immediately inform the enforcing authority.
8. They must also cooperate with and provide information, in Maltese or in English, to enforcing authorities following any requests.

Obligations of authorised representatives

Manufacturers are able to appoint authorised representatives, by written mandates, to perform certain tasks on their behalves. The manufacturers’ obligations for the electrical and electronic equipment to be designed and manufactured in accordance with the essential requirements and to draw up the technical documentation, shall not be part of these mandates.

The obligations of authorised representatives include:

1. They must comply with all the duties as specified in the mandates, including the obligation for retention of technical documentation and EU Declaration of Conformity, and the provision of information and co-operation.

Obligations of importers

The obligations of importers include:

1. Before placing electrical and electronic equipment on the market, an importer must ensure that it complies with the regulations.
2. The importer must ensure that the conformity assessment has been carried out by the manufacturer; the manufacturer has drawn up the technical documentation and the EU Declaration of Conformity; the electrical and electronic equipment is CE marked and is accompanied by the required documents and information regarding the manufacturer.
3. The importer must provide their name, registered trade name or registered trademark and an address at which they can be contacted, on the electrical and electronic equipment.
4. The importer must keep a copy of the EU Declaration of Conformity and the technical documentation for a period of 10 years after the equipment has been placed on the market.
5. The importer must keep a register of non-conforming electrical and electronic equipment and product recalls, while keeping distributors informed.
6. The importer must take action where they have reason to believe that the electrical and electronic equipment that they have placed on the market is not in conformity with the regulations. The importer must inform the manufacturer and the enforcing authority.
7. They must also cooperate with and provide information, in Maltese or in English, to enforcing authorities following any requests.

Obligations of distributors

The obligations of distributors include:

1. Before making electrical and electronic equipment available on the market, a distributor must act with due care in relation to the requirements applicable. They must verify that the equipment bears the CE marking, and is accompanied by the required documents, either in Maltese or in English. The distributor must also make sure that the obligations on the manufacturer and importer regarding their identification has been complied with.
2. The distributor must not make any equipment available on the market, until the equipment has been brought into conformity with the regulations or if they have a reason to believe that the equipment is non-conforming where then they must inform the enforcing authority.
3. The distributor must take action where they have reason to believe that the equipment that they have made available on the market is not in conformity with the regulations.
4. They must also cooperate with and provide information to enforcing authorities following any requests.

Obligations of manufacturers applying to importers and distributors

Importers or distributors are considered manufacturers for the purposes of the regulations and they are subject to the obligations of the manufacturers, where they place electrical and electronic equipment on the market under their name or trademark or modifies the equipment already placed on the market in such a way that compliance with the regulations may be affected.

Enforcement and penalties

The regulations provide powers to Technical Regulations Division (TRD), within MCCAA, to take action against economic operators for products that are not in conformity with the regulations. TRD is required to take all appropriate measures to withdraw from the market or to prohibit or to restrict the supply of products bearing CE Marking which may endanger the health and safety of persons, property or the environment.

 Economic operators are required to co-operate with the enforcement authority and on request, must provide information and take action as appropriate. Economic operators failing to comply with the requirements of the regulations are subject to the provisions of article 26 of the Product Safety Act.

Further Information

The European Commission has produced detailed guidance on the provisions of the RoHS Directive and its requirements, which should be referred to for further guidance.

This guidance can be found at: https://ec.europa.eu/environment/waste/rohs_eee/index_en.htm

The European Commission has produced guidance regarding CE marking, which can be found at: https://ec.europa.eu/growth/single-market/ce-marking

The European Commission has produced guidance called the Blue Guide intended to contribute to a better understanding of EU product safety rules and to their more uniform and coherent application across different sectors and throughout the single market. The Blue Guide can be found at: http://ec.europa.eu/DocsRoom/documents/18027/

The Environment & Resources Authority (ERA) is the responsible local authority that manages the environmentally sound recovery and disposal of waste electrical and electronic equipment (WEEE). The ERA website provides more information on WEEE, here.

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