EXPLANATORY MEMORANDUM
1.CONTEXT OF THE DELEGATED ACT
This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex III of Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) 1 (RoHS 2) as regards an exemption for specific applications containing lead.
RoHS 2 restricts the use of certain hazardous substances in electrical and electronic equipment, as provided for in its Article 4. It entered into force on 21 July 2011.
The restricted substances are listed in Annex II to RoHS 2. While the restrictions of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers are in force to date, the restrictions of bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall apply from 22 July 2019 or later. Annexes III and IV to RoHS 2 list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS 2 Article 4(1).
Article 5 makes provision for the adaptation to scientific and technical progress (inclusion, renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 2 and where any of the following conditions is fulfilled: 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; or 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.
Furthermore, Article 5(1) provides that the European Commission (the Commission) shall include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and Annex V establish the procedure for submitting applications for granting, renewing, or revoking an exemption.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
Since the publication of RoHS 2, the Commission has received numerous 3 requests from economic operators, according to the provisions in Article 5(3) and Annex V, for both granting new and renewing existing exemptions.
The current Annex III exemption 18(b) permits the use of lead as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb). The Commission received two applications for renewal of this exemption in December 2014 and January 2015. While exemption 18(b) had 21 July 2016 as expiration date for categories 1 to 7 and 10 4 , in line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the renewal application is taken by the Commission. Moreover, the Commission received in January 2015 a request no. 2015-3 for a new exemption to be added to Annex IV for discharge lamps when used as phototherapy lamps containing phosphors. As the assessment showed that it is mechanically possible that a lamp intended for medical use can fit in tanning equipment and vice versa, it was decided to merge these exemption requests under the assessment of exemption 18(b).
With a view to evaluating the application for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including an eightweek online openended stakeholder consultation 5 on the application. One contribution was made to the stakeholder consultation.
The final report containing the assessment of the application was published 6 ; stakeholders were notified.
Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS 2 during an expert meeting on 15 December 2016, which also involved presentations from the applicants and stakeholders most concerned. The experts agreed with the draft presented by the Commission, with a large majority of absent or silent members. In accordance with the Better Regulation Guidelines, the draft Delegated Directive was published on the Better Regulation Portal for a four-week public feedback period. Two comments were received, both addressing the issue of categories applicable to the wording of the draft Delegated Directive. The comments were taken into account and the draft Delegated Directive was correspondingly amended. During the second four-week public feedback period following this amendment, four comments were received, all of them supporting the draft Delegated Directive, with one requesting an immediate applicability and longer validity period. All necessary steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed. 7 The Council and the European Parliament were notified of all activities.
The final report highlighted in particular the following technical information and assessment:
·Lead activator in the fluorescent powder is required to allow the barium silicate phosphor to fluoresce. It transforms the 254 nm radiation to the designed UV (290nm-400nm) radiation and it is used in over 95% of the indoor low pressure mercury vapour fluorescent lamps in tanning and certain medical applications. It provides UV intensity at the wavelength of 350 nm that is crucial in order to initiate skin pigmentation (tanning result).
·Tanning equipment is strictly regulated in the EU and any possible alternative to lead would have to fulfil criteria on reliability, safety and health risk concerns. Currently, there are no such alternatives available and the substitution of lead hence is scientifically and technically impracticable.
The evaluation results for category 1 to 7 and 10 show the specific exemption is consistent with Regulation (EC) No 1907/2006 (REACH) and thus does not weaken the environmental and health protection afforded by it, in accordance with Article 5 of Directive 2011/65/EU. Furthermore, at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request relating to entry 18(b) in Annex III. Since for the applications concerned, no sufficiently reliable alternatives are available today or are likely to come on the market soon, validity period until 21 July 2021 is justified; as reliable substitutes are not yet available, no negative socioeconomic impacts of substitution are to be anticipated for this period. The granted validity period is also not expected to have adverse impacts on innovation. Furthermore, in view of request no. 2015-3 and the fact that it is mechanically possible that a lamp intended for medical or tanning use can fit in the same luminaire or equipment, a new sub-entry to the exemption 18(b) specific to medical applications (except those covered under point 34 of Annex IV) shall be added.
For categories other than categories 1 to 7 and 10, the existing exemption remains as per the validity periods set out in Article 5(2).
3.LEGAL ELEMENTS OF THE DELEGATED ACT