REACH is a horizontal legislation controlling the risks associated with chemical substances throughout their whole life cycle, while RoHS is a product-specific vertical legislation focuses on hazardous substances in electrical and electronic equipment (EEE). Although their scopes partially overlap, they were designed to be complementary.
RoHS 2 Directive - Scope of Application for Electrical and Electronic Equipment
On 21 July 2011, RoHS 2 Directive (2011/65/EU) on the restriction of the use of certain hazardous substances in EEE, came into force, and required EU member states to implement national measures by 2 January 2013. The purpose of the Directive is to protect human health and the environment through banning the placing on the market of products that contain hazardous substances in specific concentrations.
Although the scope of RoHS does not cover the manufacturing process, risks arising at that stage have already been considered for the listing of substances in Annex II of the Directive. Such methodology of substances listing is consistent with the one under REACH. When conditions for the placing on the market of EEE are being established, RoHS takes into consideration waste management and recycling, which have a greater potential for exposure of humans and the environment than the manufacturing process does.
Application Scope for RoHS and REACH - A Common Understanding
REACH applies to all substances (in mixtures or in articles), including those in EEE that fall under the scope of RoHS. This shows where the scopes of the two legislations overlap. However, based on the European Commission Document "REACH and Directive 2011/65/EU (RoHS) - A Common Understanding" (Doc. CA/36/2014), RoHS should be given priority over REACH for issues concerning the use of substances in EEE. The document explores the management of future regulatory action on the same chemical substances under both REACH and RoHS. Specific scenarios concerning restrictions and authorization requirements are presented.
Restriction of Substances under RoHS vs Restriction under REACH Annex XVII
RoHS listed vs REACH (Annex XVII) proposed - How to manage future regulatory action?
- REACH should exclude EEE from the scope of the restriction.
- The entry in Annex XVII of REACH should indicate that the use of the substance in question in EEE is restricted by the RoHS Directive.
RoHS proposed vs REACH (Annex XVII) listed - How to manage future regulatory action?
When RoHS requires taking action in order to establish the same or more stringent measures for EEE:
- Annex XVII of REACH would need to be amended to remove EEE from the scope of the restriction.
- The entry in Annex XVII should indicate that the use of the substance in question in EEE is restricted by the RoHS Directive.
Not any action yet for RoHS vs imminent proposal for REACH (Annex XVII) - How to manage future regulatory action?
- A restriction could be imposed under REACH.
- Later to be amended to exclude EEE if/when the substance is added to Annex II to RoHS.
Restricted Substances under RoHS vs Authorized Substances under REACH
RoHS listed vs REACH (Annex XIV) proposed - How to manage future regulatory action?
Where RoHS has not provided an exemption for the use of the substances:
- The placing on the market of EEE containing the banned substance is prohibited.
- The authorization requirement under REACH would apply.
Where RoHS provides an exemption for the use of the substance:
- EEE containing that banned substance may be placed on the market in specified cases.
- Incorporation of the substance in EEE by EU manufacturers would be subject to the authorization procedure under REACH.
- Possibility is open to exempt the uses covered by the RoHS restriction from the authorization process under REACH.
RoHS proposed vs REACH (Annex XIV) listed - How to manage future regulatory action?
Where RoHS restricts without exemptions:
- The placing on the market of EEE containing the banned substance is prohibited.
- The authorization requirement under REACH would apply, but there would be no demand for the authorized use of the substance as the substance is proposed to be prohibited under RoHS.
Where RoHS restricts with exemptions, there will be a need to consider whether there is added value in continuing the authorization requirement under REACH for those exempted applications under RoHS.
Not yet any action, but risk management measures are considered - How to manage future regulatory action?
To include the substance in Annex XIV to REACH and exempt the incorporation of the substance in EEE later, or to delay the REACH procedure, waiting for inclusion of the substance as a RoHS restriction.
By analyzing these above-mentioned scenarios, the Document aims to establish a 'common understanding' on how chemicals under REACH and RoHS should be managed. The Common Understanding document should be taken into consideration in REACH Risk Management Options (RMO) analysis procedures, as well as in the framework of the 2020 Substances of Very High Concern (SVHC) roadmap.
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