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EU 2015/863: Restriction of Hazardous Substances (RoHS) -3

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Abstract

The European Parliament and the Council of the European Union, with regard to the Treaty on the Functioning of the European Union, a proposal from the European Commission, an opinion of the European Economic and Social Committee, an opinion of the Committee regions, and in accordance with the legislative procedure, has laid down restrictions on the use of hazardous substances in electrical and electronic equipment (EEE). This enables to prevent the occurrence of any barriers between the safety of human health and environment and trade and competition. The Council Resolution stresses that the Commission should pursue measures to combat cadmium pollution by restricting its use and encouraging alternatives. The Member States cannot effectively protect the environment and human health against pollutants because of the transboundary effects of pollutants. Hence, the European Parliament and Council recommend that measures should be taken at Union level such that the organic pollutants such as dioxins and furans should be identified and reduced and ultimately eliminated whenever possible [1]. The collection, treatment, recycling, and disposal of waste of EEE are essential to reduce problems arising from heavy metals and flame retardants. In spite of these regulations, waste from EEE (mercury, cadmium, lead, chromium VI, polybrominated biphenyls (PBB)) and polybrominated diphenyl ethers (PBDE) would be present in the disposal even if collected and recycled separately and pose a risk to human health and the environment [2]. The regulation takes into account the technical and economic feasibility of small and medium-sized enterprises (SMEs) to find an effective way of ensuring the reduction and substitution of hazardous substances in EEE. By restricting it can enhance profitability and the possibility of recycling waste EEE and reducing risk to health and environment at the recycling plants. In the measures provided under this regulation, international guidelines have to be considered and compactions and the assessment of scientific and technical information recommended. The measures have to be constantly reviewed and updated to achieve the chosen level of protection of human health and environment. Particularly, risks due to hexabromocyclododecane, bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), and dibutyl phthalate (DBP) should be prioritized. Therefore, Annexes XIV (List of substances subject to authorization) and XVII (Restrictions on the manufacture, placing on the market, and use of certain dangerous substances, preparations, and articles) to Regulation (EC) No 1907/2006 of the European Parliament and of the Council should be periodically reviewed and updated. This Directive also gives the general Union waste management legislation [3]. Definitions are also included to specify the scope and multipurpose character to determine the functions of EEE based on its characteristics, design, and marketing. Ecological designing specifications of EEE in energy-related products such as batteries and accumulators are also included in this directive, along with other Directives [4, 5]. Based on the scientific evidence it should be examined that substances classified as hazardous owing to their very small internal surface and structure such as nanomaterials and substituted with more environmentally friendly alternatives. This regulation holds the list of restricted substances in Annex II in coherence with Regulation (EC) No 1907/2006. This directive should not prevent the development of renewable energy technologies that cause no negative impact on health and the environment [6]. The substitutions of hazardous substances in EEE should consider the health and safety of users. Exemptions from these substitutions are made if it is not possible from a scientific and technical point of view, taking into account the availability of substitutes and the socioeconomic impact. The situation of SMEs should also be taken into account, and whether the negative environmental, health, and consumer safety impacts of the substitution outweigh the environmental, health, and consumer safety benefits of the substitution. This also applies to materials used in medical devices. The safety of the potential substitute for a medical or in vitro diagnostic device is not demonstrated, then it should be regarded to have a negative impact on socioeconomic, health, and consumer safety [7]. The exemptions for substitutions should be limited in order to facilitate the phasing-out of hazardous substances in EEE. The procedure for harmonizing conformity in the assessment of EEE is given under this directive and should conform with the Union legislation [8]. The EEE should be marked with CE markings when marketed and the market surveillance mechanisms govern the requirements for the accreditation and marketing of these products [9]. The Commission is empowered to implement power to ensure conformity with regard to guidelines laid out under this directive. The restrictions under this directive are governed both by the Member States and at Union Level.

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References

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Sriram, H., Jagadeeswaran, I. (2022). EU 2015/863: Restriction of Hazardous Substances (RoHS) -3. In: Timiri Shanmugam, P.S., Thangaraju, P., Palani, N., Sampath, T. (eds) Medical Device Guidelines and Regulations Handbook. Springer, Cham. https://doi.org/10.1007/978-3-030-91855-2_15

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  • DOI: https://doi.org/10.1007/978-3-030-91855-2_15

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