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The use of substances with hazardous properties has been regulated by law for decades. Increasing public awareness and intensified official enforcement practices are bringing the area of substance-related specifications for products further into focus. For manufacturers of electrical and electronic equipment (electrical appliances) in particular, it is not only essential to know the applicable substance restrictions and corresponding exemptions. Manufacturers should also proactively contribute to the further development of regulatory requirements in this area.
In this context, it should be noted that the scope of Directive 2011/65/EU (RoHS) is very broad and machinery within the meaning of Article 2 (a) of Directive 2006/42/EC may also be electrical equipment within the meaning of Article 3(1) RoHS in individual cases. Exemptions from the scope of application of RoHS exist, among others, for "large-scale stationary industrial tools" (Article 3 (3) RoHS) and "large-scale fixed installations" (Article 3 (4) RoHS), which, however, are to be interpreted narrowly due to their exceptional nature (for detailed definitions, see Chapter 3 of the document: FAQ RoHS 2 (as of 12 December 2012))).
This article provides information on the current status of substance restrictions (see Chapter A) and exemptions (see Chapter B) in accordance with RoHS, implemented in Germany by the Regulation on the Restriction of the Use of Hazardous Substances in Electrical and Electronic Equipment (ElektroStoffV). The article also shows what developments can be expected in this area and to what extent there will probably be opportunities for participation.
Firstly, the existing substance restrictions, including the relevant definitions, are explained in section I below. On this basis, Section II then describes the current developments to be expected in the area of substance restrictions for electrical appliances.
Currently, Article 4(1) in conjunction with Annex II RoHS contains restrictions for the following ten substances:
A limit value of 0.01 per cent by weight applies for cadmium and a limit value of 0.1 per cent by weight for all other substances. The percentage refers to the individual so-called "homogeneous material". In Article 3 No. 20 RoHS, "homogeneous material" is defined as "material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes". In the case of a cable, for example, a distinction must be made between the copper wire core and the insulation, as these are two homogeneous materials to be assessed separately from each other in the sense described.
It should be noted in this context that the reference point under RoHS is therefore different from that under Regulation (EC) No. 1907/2006 (REACH). For the determination of the 0.1% threshold in connection with notification and information obligations regarding so-called substances of very high concern (SVHC) in accordance with Article 7(2) and Article 33 REACH, the REACH Regulation is based on the individual article, which in individual cases may well consist of several homogeneous materials within the meaning of RoHS. This is the case, for example, with a painted housing, which is a single article according to the REACH Regulation, but according to the RoHS Directive consists of (at least) two homogeneous materials (paint layer and housing material as such). The two regimes should therefore always be considered separately, despite some overlaps.
For example, there are no specific exemptions under the REACH Regulation that would exclude information obligations under Article 33 REACH in individual cases. In contrast, however, the substance bans under Article 4(6) RoHS do not apply by way of exception if a substance- and use-related exemption provision contained in Annexes III or IV RoHS is relevant (see point B. for details).
Violations of the aforementioned substance restrictions constitute an administrative offence under the ElektroStoffV applicable in Germany and can be punished with a fine of up to EUR 100,000.00 per violation. In addition, electrical appliances that violate the substance restrictions are subject to both an absolute ban on marketing at all stages of the supply chain (including downstream) and a requirement to take all necessary corrective measures with regard to electrical appliances that have already been placed on the market in the event of suspected or recognised violations. Depending on the potential risk, this can lead to a recall of all affected electrical appliances that have already been sold.
Since 2019, two substances have been proposed for inclusion in the list of substance restrictions under RoHS by the Öko-Institut e.V. - Institute for Applied Ecology, which was commissioned by the European Commission to evaluate the substances. These are the following two substances:
TBBP-A, which is mainly used as a component of epoxy resins (for example in FR-4 PWB composites) and as a flame retardant, is to be included in the list of restricted substances with a limit value of 0.1%. According to the Öko-Institut's restriction proposal (available at: ROHS Annex II Dossier for TBBP-A) this limit value ensures that only additive applications as flame retardants are covered, as a residual concentration of TBBP-A of 0.1% is generally not exceeded when TBBP-A is used in epoxy reactions in the finished material.
MCCPs are generally understood to be a group of medium-chain chlorinated paraffins, which differ from each other in terms of their chain length and degree of chlorination. In the electrical industry, MCCPs are mainly used in PVC plastics and rubber cable insulation due to their flame-retardant properties. With regard to MCCPs, the evaluating Öko-Institut also proposes a limit value of 0.1% in the underlying restriction proposal (available at: ROHS Annex II Dossier MCCPs). As MCCPs are a so-called UVCB substance (Unknown or Variable composition, Complex reaction products or Biological materials) within the meaning of the REACH Regulation due to their variable composition, a supplementary substance definition should be added to the restriction in order to ensure an exact differentiation from other substance groups. The MCCP restriction should therefore cover chlorinated paraffins that contain paraffins with a chain length of C14-17 - linear or branched.
With regard to a third substance - diantimony trioxide - the Oeko-Institut also proposed further testing in 2019. Diantimony trioxide is mainly used as a synergist for halogenated flame retardants in order to reduce the use of halogenated flame retardants. The main areas of application are plastics for housings, cables and printed circuit boards. The Oeko-Institut assumes that an isolated restriction for diantimony trioxide alone would lead to a (renewed) increase in the use of halogenated flame retardants that are harmful to health and the environment, which could reverse the hoped-for positive effects of a restriction. In order to avoid this, the Öko-Institut proposed (see: ROHS Annex II Dossier for Diantimony trioxide), not to restrict diantimony trioxide exclusively, but to carry out a joint assessment together with the halogenated flame retardants. However, this assessment does not appear to have progressed any further since then.
With regard to the three substances mentioned (TBBP-A, MCCP and diantimony trioxide), there was an opportunity to submit comments on the planned measures to the Oeko-Institut from 5 December 2019 to 30 January 2020 as part of a public consultation, which will be taken into account in the Oeko-Institut's final proposal to the European Commission. Based on the Oeko-Institut's proposal, the European Commission will decide on the inclusion of the substances in Annex II RoHS in accordance with Article 6 in conjunction with Articles 20 to 22 RoHS. Due to the lack of legal provisions on the timeline, it is currently still unclear when the European Commission will reach a final decision on the inclusion of the substances in Annex II. Although the EU Commission formally launched a procedure to include the two substances in the list of restricted substances in 2022, this has not been pursued very actively since then and there is still no draft legal act for inclusion in the list of restricted substances. However, it can be assumed that a possible restriction will not apply immediately, but that a transitional period of several years will be granted during which the companies affected can adjust to the new restrictions.
Other substances that were also evaluated in 2019 were not proposed by the Oeko-Institut for inclusion in the list of RoHS substance restrictions. These are the following substances: cobalt dichloride and cobalt sulphate, nickel sulphate and nickel sulphamate, beryllium and its compounds and indium phosphide.
In addition to the substances mentioned here, there is a longer list of 43 substances (available at: Substance Prioritisation), which are gradually evaluated in chronological stages with regard to their inclusion in Annex II RoHS. This also includes common substances such as nickel and zinc oxide. By 2020, certain information on substance quantities and uses could be submitted to the evaluating Oeko-Institut for these substances as part of an initial consultation phase, which will be incorporated into the further evaluation process. However, no progress is currently discernible for these substances either.
There are numerous substance and use-related exemptions from the substance restrictions under Article 4(1) in conjunction with Annex II RoHS in accordance with Article 4(6) in conjunction with Annexes III and IV RoHS. By the beginning of 2020, applications for extensions had to be submitted for numerous exemptions in order to ensure their applicability beyond 21 July 2021 (see point II). In order to better categorise the current processes, a basic classification of exemptions from RoHS substance restrictions is provided first under point I.
The exemptions from the substance restrictions contained in Annex III and IV RoHS mean that these do not have to be complied with in relation to the substance and use specified in the exemption. Exemptions can be provided for completely without limit values or in turn provide for their own limit values. It should always be noted that exemptions are always only limited to a certain period of time and a new application for renewal is required to extend the exemption. The exemptions are not granted on a company-specific basis, but are generally valid. However, companies that apply an exemption provision should ensure that, firstly, extension applications are submitted in good time and, secondly, that a favourable decision is made on these extension applications.
According to Article 5(5) RoHS, an application for renewal must be submitted at least 18 months before the respective exemption expires. Only then does the privilege also contained in Article 5(5) RoHS apply that the exemption remains valid until the European Commission has decided on the renewal application. Otherwise, the exemption expires and can no longer be used to overcome the substance restrictions from the time it expires. In such a case, an application for the inclusion of a new exemption is required, which, however, can only be utilised once a positive decision on the application has been made.
The current status of exemptions, including extension requests and applicable expiry dates, is published at irregular intervals by the EU Commission in the document ‘Exemptions list - validity and rolling plan’. This document was last updated on 28 July 2025 and is available on the EU Commission's website.
Due to the 18-month deadline explained above, applications for extensions had to be submitted to the European Commission by 20 January 2020 for numerous exemptions that are limited until 21 July 2020 (see RoHS 2 exemptions - Validity and rolling plan - status: 6 September 2023). In particular, this also affects the exemptions from the lead restriction under points 6 and 7 of Annex III RoHS and from the cadmium restriction under point 8 RoHS, which are relevant in all sectors.
For many of these exemptions, which are limited until 21 July 2021, there is the special situation that the European Commission has not yet made a decision on the extension applications submitted in 2015 for an extension from 21 July 2016 to 21 July 2021. In other words, this means that the extension applications had to be submitted in the current extension round without it being clear whether an extension until 21 July 2021 will take place at all. Nevertheless, applications for extension were necessary, as the temporary extension of a derogation is always calculated from the date of its formal expiry and not only from the date of the European Commission's extension decision.
However, no decision has yet been made on the majority of the extension applications submitted in 2019/2020, although the assessments and proposals from the external assessment institutions have long been available. According to information provided by the EU Commission in February 2024, the assessment of points 6 and 7 of Annex III RoHS is linked to other assessments and has therefore been postponed until these assessments have also been completed.
In the further course of time, companies that currently rely on an exemption provision are advised to find out whether this exemption provision will continue to be valid and, if necessary, to participate in public consultation procedures regarding the extension of the exemption provisions in order to support an extension by submitting relevant data and arguments.
This proposal is currently still in the legislative process of the EU institutions. However, it can be assumed that this will be finalised this year, although the EU elections may cause a further delay.
In light of increased regulatory activities in the area of substance restrictions for electrical appliances, affected companies, regardless of whether they are manufacturers, importers or mere distributors, should establish suitable compliance processes to ensure that no electrical appliances are placed on the market that violate the applicable substance restrictions. Failure to do so may result in bans on placing on the market, orders for necessary corrective measures and not inconsiderable fines. In order to avoid being surprised by current developments, early involvement in relevant legislative procedures, either by actively drafting the necessary proposals or by reactively commenting on published proposals as part of regular consultation procedures, is just as important as continuous monitoring of applicable legal regulations at both European and national level.
Posted on: 2025-08-18 (last amendment)
Michael Öttinger Michael Öttinger specialises in advising on chemicals law (REACH, CLP and national chemicals legislation), electrical and electronic equipment law (WEEE/ElektroG and RoHS/ElektroStoffV) and packaging, dangerous goods and biocide law.
E-mail: oettinger@produktkanzlei.com | www.produktkanzlei.com