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OJ L , 1. In force: This act has been changed.
Having regard to the Treaty on the Functioning of the European Union, and in particular Article thereof,. In the interest of clarity, that Directive should be recast.
The disparities between the laws or administrative measures adopted by the Member States regarding the restriction of the use of hazardous substances in electrical and electronic equipment EEE could create barriers to trade and distort competition in the Union and may thereby have a direct impact on the establishment and functioning of the internal market.
It therefore appears necessary to lay down rules in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste EEE. Prevention is defined, inter alia, as measures that reduce the content of harmful substances in materials and products.
Human health also has to be protected and an overall strategy that in particular restricts the use of cadmium and stimulates research into substitutes should therefore be implemented. The Resolution stresses that the use of cadmium should be limited to cases where suitable alternatives do not exist. Pursuant to that Regulation, releases of persistent organic pollutants, such as dioxins and furans, which are unintentional by-products of industrial processes, should be identified and reduced as soon as possible with the ultimate aim of elimination, where feasible.
In spite of those measures, however, significant parts of waste EEE will continue to be found in the current disposal routes inside or outside the Union. Even if waste EEE were collected separately and submitted to recycling processes, its content of mercury, cadmium, lead, chromium VI, polybrominated biphenyls PBB and polybrominated diphenyl ethers PBDE would be likely to pose risks to health or the environment, especially when treated in less than optimal conditions.
Taking into account technical and economic feasibility, including for small and medium sized enterprises SMEs , the most effective way of ensuring a significant reduction of risks to health and the environment relating to those substances, in order to achieve the chosen level of protection in the Union, is the substitution of those substances in EEE by safe or safer materials.
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Restricting the use of those hazardous substances is likely to enhance the possibilities and economic profitability of recycling of waste EEE and decrease the negative impact on the health of workers in recycling plants. The substances covered by this Directive are scientifically well researched and evaluated and have been subject to different measures both at Union and at national level.
The measures provided for in this Directive should take into account existing international guidelines and recommendations and should be based on an assessment of available scientific and technical information. The measures are necessary to achieve the chosen level of protection of human health and the environment, with due respect for the precautionary principle, and having regard to the risks which the absence of measures would be likely to create in the Union. The measures should be kept under review and, if necessary, adjusted to take account of available technical and scientific information.
With a view to further restrictions of substances, the Commission should re-investigate the substances that were subject to previous assessments, in accordance with the new criteria set out in this Directive as part of the first review. A number of definitions should be included in this Directive in order to specify its scope. As soon as scientific evidence is available, and taking into account the precautionary principle, the restriction of other hazardous substances, including any substances of very small size or with a very small internal or surface structure nanomaterials which may be hazardous due to properties relating to their size or structure, and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined.
Consultation with the relevant stakeholders should be carried out and specific account should be taken of the potential impact on SMEs. Consequently, this Directive should not prevent the development of renewable energy technologies that have no negative impact on health and the environment and that are sustainable and economically viable.
Exemptions from the substitution requirement should be permitted if substitution is not possible from the scientific and technical point of view, taking specific account of the situation of SMEs or if the negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the environmental, health and consumer safety benefits of the substitution or the reliability of substitutes is not ensured.
The decision on exemptions and on the duration of possible exemptions should take into account the availability of substitutes and the socioeconomic impact of substitution. Life-cycle thinking on the overall impacts of exemptions should apply, where relevant.
Substitution of the hazardous substances in EEE should also be carried out in such a way as to be compatible with the health and safety of users of EEE. If such a notified body certifies that the safety of the potential substitute for the intended use in medical devices or in vitro diagnostic medical devices is not demonstrated, the use of that potential substitute will be deemed to have clear negative socioeconomic, health and consumer safety impacts.
It should be possible, from the date of entry into force of this Directive, to apply for exemptions for equipment, even before the actual inclusion of that equipment in the scope of this Directive. Exemptions from the restriction for certain specific materials or components should be limited in their scope and duration, in order to achieve a gradual phase-out of hazardous substances in EEE, given that the use of those substances in such applications should become avoidable.
As product reuse, refurbishment and extension of lifetime are beneficial, spare parts need to be available. Harmonising conformity assessment procedures should give manufacturers legal certainty as to what they have to provide as proof of compliance to the authorities throughout the Union.
In order to ensure uniform conditions for the implementation of this Directive, particularly with regard to the guidelines and format of applications for exemptions, implementing powers should be conferred on the Commission. For the purposes of achieving the objectives of this Directive the Commission should be empowered to adopt delegated acts in accordance with Article of the Treaty on the Functioning of the European Union in respect of amendments to Annex II, detailed rules for complying with maximum concentration values, and the adaptation of Annexes III and IV to technical and scientific progress.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Restriction of Hazardous Substances in Electrical and Electronic Equipment
The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with the earlier Directive. The obligation to transpose the provisions which are unchanged arises under the earlier Directive.
This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directive set out in Annex VII, Part B. Since the objective of this Directive, namely to establish restrictions on the use of hazardous substances in EEE, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the problem and its implications in respect of other Union legislation on recovery and disposal of waste and areas of common interest, such as human health protection, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective,. This Directive lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment EEE with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE.
The functionality of EEE is restored or is upgraded when the part is replaced by a spare part;. Member States shall ensure that EEE placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, does not contain the substances listed in Annex II. For the purposes of this Directive, no more than the maximum concentration value by weight in homogeneous materials as specified in Annex II shall be tolerated.
The Commission shall adopt, by means of delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22, detailed rules for complying with these maximum concentration values taking into account, inter alia, surface coatings.
Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July , to in vitro diagnostic medical devices which are placed on the market from 22 July and to industrial monitoring and control instruments which are placed on the market from 22 July Paragraph 1 shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following:.
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EEE which benefited from an exemption and which was placed on the market before that exemption expired as far as that specific exemption is concerned.
Paragraph 1 shall not apply to reused spare parts, recovered from EEE placed on the market before 1 July and used in equipment placed on the market before 1 July , provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer.
For the purposes of adapting Annexes III and IV to scientific and technical progress, and in order to achieve the objectives set out in Article 1, the Commission shall adopt by means of individual delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22, the following measures:.
Decisions on the inclusion of materials and components of EEE in the lists in Annexes III and IV and on the duration of any exemptions shall take into account the availability of substitutes and the socioeconomic impact of substitution. Decisions on the duration of any exemptions shall take into account any potential adverse impacts on innovation.
Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant;. Measures adopted in accordance with point a of paragraph 1 shall, for categories 1 to 7, 10 and 11 of Annex I, have a validity period of up to 5 years and, for categories 8 and 9 of Annex I, a validity period of up to 7 years.
The validity periods are to be decided on a case-by-case basis and may be renewed.
For the exemptions listed in Annex III as at 21 July , the maximum validity period, which may be renewed, shall, for categories 1 to 7 and 10 of Annex I, be 5 years from 21 July and, for categories 8 and 9 of Annex I, 7 years from the relevant dates laid down in Article 4 3 , unless a shorter period is specified. For the exemptions listed in Annex IV as at 21 July , the maximum validity period, which may be renewed, shall be 7 years from the relevant dates laid down in Article 4 3 , unless a shorter period is specified.
An application for granting, renewing or revoking an exemption shall be made to the Commission in accordance with Annex V. The acknowledgement shall state the date of receipt of the application;. An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall decide on an application for renewal of an exemption no later than 6 months before the expiry date of the existing exemption unless specific circumstances justify other deadlines.
The existing exemption shall remain valid until a decision on the renewal application is taken by the Commission.
Directive (EU) 2015/863 Amends EU RoHS to Restrict 4 New Phthalates: DEHP, BBP, DBP and DIBP
In the event that the application for renewal of an exemption is rejected or that an exemption is revoked, the exemption shall expire at the earliest 12 months, and at the latest 18 months, after the date of the decision. Before Annexes are amended, the Commission shall, inter alia, consult economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations and make the comments received publicly available. The Commission shall adopt a harmonised format for applications referred to in paragraph 3 of this Article as well as comprehensive guidelines for such applications, taking into account the situation of SMEs.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 19 2. With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and amendment of the list of restricted substances in Annex II shall be considered by the Commission before 22 July , and periodically thereafter on its own initiative or following the submission of a proposal by a Member State containing the information referred to in paragraph 2.
The review shall use publicly available knowledge obtained from the application of such legislation. In order to review and amend Annex II, the Commission shall take special account of whether a substance, including substances of very small size or with a very small internal or surface structure, or a group of similar substances:.
Restriction of Hazardous Substances Directive
During that review, the Commission shall consult interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations. The proposals to review and amend the list of restricted substances, or a group of similar substances, in Annex II shall contain at least the following information:.
The measures referred to in this Article shall be adopted by the Commission by means of delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4 1 of this Directive may be demonstrated within the context of that procedure.
A single technical documentation may be drawn up;. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of EEE is declared shall be adequately taken into account;. The address must indicate a single point at which the manufacturer can be contacted.
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The mandate shall allow the authorised representative to do at least the following:. Member States shall ensure that an importer or distributor is considered a manufacturer for the purposes of this Directive and that he is subject to the obligations of the manufacturer under Article 7, where he places EEE on the market under his name or trademark or modifies EEE already placed on the market in such a way that compliance with the applicable requirements may be affected.
Member States shall ensure that economic operators, on request, identify the following to the market surveillance authorities, for 10 years following the placing on the market of the EEE:.
The EU declaration of conformity shall state that it has been demonstrated that the requirements specified in Article 4 have been met. The EU declaration of conformity shall have the model structure and shall contain the elements specified in Annex VI and shall be updated.
It shall be translated into the language or languages required by the Member State on the market of which the product is placed or made available. A single technical documentation may be drawn up. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE with this Directive.
The CE marking shall be affixed visibly, legibly and indelibly to the finished EEE or to its data plate. Where that is not possible or not warranted on account of the nature of the EEE, it shall be affixed to the packaging and to the accompanying documents. Member States shall build upon existing mechanisms to ensure the correct application of the regime governing the CE marking and take appropriate action in the event of improper use of the CE marking.
Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
Materials, components and EEE on which tests and measurements demonstrating compliance with the requirements of Article 4 have been performed, or which have been assessed, in accordance with harmonised standards, the references of which have been published in the Official Journal of the European Union , shall be presumed to comply with the requirements of this Directive.
The Committee shall, after consulting the relevant European standardisation bodies, deliver its opinion without delay.
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The Commission shall inform the European standardisation body concerned and, if necessary, request the revision of the harmonised standards concerned.
The powers to adopt the delegated acts referred to in Article 4 2 , Article 5 1 and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5 year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 21 and The delegation of power referred to in Article 4 2 , Article 5 1 and Article 6 may be revoked at any time by the European Parliament or by the Council.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.