EdLaw
The restricted substances and exemption machinery
The Article 4 prevention duty, the ten restricted substances with their maximum concentration values in homogeneous materials (Annex II), and how Annex III/IV exemptions are granted and reviewed. The exemption lists themselves (Annexes III–IV) are long and application-specific and are not reproduced — consult them on EUR-Lex.
Article 4 — Prevention
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
1. 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.
2. 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.
3. Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diagnostic medical devices which are placed on the market from 22 July 2016, to industrial monitoring and control instruments which are placed on the market from 22 July 2017, and to all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market from 22 July 2019.
4. 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:
- (a) EEE placed on the market before 1 July 2006;
- (b) medical devices placed on the market before 22 July 2014;
- (c) in vitro diagnostic medical devices placed on the market before 22 July 2016;
- (d) monitoring and control instruments placed on the market before 22 July 2014;
- (e) industrial monitoring and control instruments placed on the market before 22 July 2017;
- (ea) all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market before 22 July 2019;
- (f) 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.
5. Provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of spare parts is notified to the consumer, paragraph 1 shall not apply to reused spare parts:
- (a) recovered from EEE placed on the market before 1 July 2006 and used in EEE placed on the market before 1 July 2016;
- (b) recovered from medical devices or monitoring and control instruments placed on the market before 22 July 2014 and used in EEE placed on the market before 22 July 2024;
- (c) recovered from in vitro diagnostic medical devices placed on the market before 22 July 2016 and used in EEE placed on the market before 22 July 2026;
- (d) recovered from industrial monitoring and control instruments placed on the market before 22 July 2017 and used in EEE placed on the market before 22 July 2027;
- (e) recovered from all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market before 22 July 2019, and used in EEE placed on the market before 22 July 2029.
Article 5 — Adaptation of the Annexes to scientific and technical progress
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
1. 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:
- (a) inclusion of materials and components of EEE for specific applications in the lists in Annexes III and IV, provided that such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 and where any of the following conditions is fulfilled: 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;
- — their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable,
- — the reliability of substitutes is not ensured,
- — the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.
- (b) deletion of materials and components of EEE from the lists in Annexes III and IV where the conditions set out in point (a) are no longer fulfilled.
2. 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 2011, unless a shorter period is specified, the maximum validity period, which may be renewed, shall be:
- (a) for categories 1 to 7 and category 10 of Annex I, 5 years from 21 July 2011;
- (b) for categories 8 and 9 of Annex I, 7 years from the relevant dates laid down in Article 4(3); and
- (c) for category 11 of Annex I, 5 years from 22 July 2019. For the exemptions listed in Annex IV as at 21 July 2011, 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.
3. An application for granting, renewing or revoking an exemption shall be made to the Commission in accordance with Annex V.
- (a) acknowledge receipt of an application in writing within 15 days of its receipt. The acknowledgement shall state the date of receipt of the application;
- (b) inform the Member States of the application without delay and make the application and any supplementary information supplied by the applicant available to them;
- (ba) within 1 month of receipt of an application, provide to the applicant, the Member States and the European Parliament a timeline for the adoption of its decision on the application;
- (c) make a summary of the application available to the public;
- (d) evaluate the application and its justification.
5. An application for renewal of an exemption shall be made no later than 18 months before the exemption expires.
————— The existing exemption shall remain valid until a decision on the renewal application is taken by the Commission.
6. 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.
7. 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.
8. 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).
Article 6 — Review and amendment of list of restricted substances in Annex II
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
1. 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 2014, 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 and amendment of the list of restricted substances in Annex II shall be coherent with other legislation related to chemicals, in particular Regulation (EC) No 1907/2006, and shall take into account, inter alia, Annexes XIV and XVII to that Regulation. 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:
- (a) could have a negative impact during EEE waste management operations, including on the possibilities for preparing for the reuse of waste EEE or for recycling of materials from waste EEE;
- (b) could give rise, given its uses, to uncontrolled or diffuse release into the environment of the substance, or could give rise to hazardous residues, or transformation or degradation products through the preparation for reuse, recycling or other treatment of materials from waste EEE under current operational conditions;
- (c) could lead to unacceptable exposure of workers involved in the waste EEE collection or treatment processes;
- (d) could be replaced by substitutes or alternative technologies which have less negative impacts. During that review, the Commission shall consult interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations.
2. 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:
- (a) precise and clear wording of the proposed restriction;
- (b) references and scientific evidence for the restriction;
- (c) information on the use of the substance or the group of similar substances in EEE;
- (d) information on detrimental effects and exposure in particular during waste EEE management operations;
- (e) information on possible substitutes and other alternatives, their availability and reliability;
- (f) justification for considering a Union-wide restriction as the most appropriate measure;
- (g) socioeconomic assessment.
3. 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 22.
ANNEX II — Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials
Verbatim from EUR-Lex (Directive 2011/65/EU (RoHS 2) 02011L0065-20260701), via the Publications Office Cellar API.
Lead (0,1 %)
Mercury (0,1 %)
Cadmium (0,01 %)
Hexavalent chromium (0,1 %)
Polybrominated biphenyls (PBB) (0,1 %)
Polybrominated diphenyl ethers (PBDE) (0,1 %)
Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
Butyl benzyl phthalate (BBP) (0,1 %)
Dibutyl phthalate (DBP) (0,1 %)
Diisobutyl phthalate (DIBP) (0,1 %)
The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.
The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.
The restriction of DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006.
Sources
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