Restricted Substances Overview in European Union


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Last Updated: August 11, 2014
Investigation: Complete
Report Contents
-   Full Report
-   Restricted Substance Reports
-   Key Documents
-   Other Documents
-   Links
-   Contacts
-   Revision History

Introduction

This report provides an overview of legislation that imposes restrictions on the use of chemical substances in electrical and electronic equipment (EEE).

Under EU law, requirements applying to chemicals in EEE products fall into the following categories:

  • Prohibitions and restrictions:
    • The new RoHS Directive (‘RoHS-2'), which entered into force on 3 January 2013) restrict the use of 6 substances in EEE, namely lead, mercury, cadmium, hexavalent chromium, PBB and PBDE, subject to various exemptions.
    • The Battery Directive restricts the use of cadmium, lead and mercury in batteries.
    • The Waste Packaging Directive restricts the use of lead, mercury, cadmium and hexavalent chromium in packaging.
    • The substance restrictions set forth in REACH, Annex XVII, and other European regulations, such as the Fluorinated Gases Regulation and the Biocide Regulation, may apply also to EEE and its packaging.
  • Conformity assessment procedure:
    • As of 3 January 2013, RoHS-2 requires producers of EEE to develop a technical file and a declaration of conformity establishing that EEE complies with RoHS-2 chemical restrictions.
    • Manufacturers, both EU and non-EU, must conduct a self-assessment (a ‘conformity assessment') with respect to EEE to be placed on the EU market.
  • Marking and labeling and information for customers and consumers:
    • RoHS-2 requires both CE-marking on the EEE and labeling, including contact information for the EEE producer.
    • REACH requires that all EEE suppliers provide to customers, and upon request, to consumers, information on safe use of EEE if it contains a substance on the Candidate List. This information, at a minimum, must include the name of the substance.
  • Supply chain management:
    • As a practical matter, EEE suppliers cannot comply with RoHS-2 and REACH without information on the composition of their products. A widely used method for EEE suppliers to gather this information is via contractual clauses or certification by their suppliers of components. This method requires supply chain management, and may avoid testing of each EEE.
  • Notification to authorities:
    • REACH requires that an EEE supplier notify ECHA if its product contains a substance on the Candidate List, except if the substance was previously registered by any person for that particular use.
  • Authorization and registration:
    • REACH requires authorization for the use, including incorporation into articles, of substances on the Authorization List. This requirement does not apply to imported articles.
    • REACH also requires registration of (1) substances intended to be released from articles, and (2) certain substances as specified by the European Chemicals Agency ("ECHA") (ECHA has not yet specified any such substance).

For substance-specific information, please refer to the EU Restricted Substance Database. Please also refer to the country reports on batteries and packaging available on IHS EIATRACK.

For the list of current and proposed exemptions from RoHS-2 chemical restrictions, see the RoHS-2 Exemption Database.

This report discusses:

  1. RoHS-2;
  2. REACH insofar as it relates to substances in EEE; and
  3. The relation between RoHS and REACH.

RoHS: RoHS-2 aims at harmonizing national law restrictions on the use of hazardous substances in EEE, and cover lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). RoHS-2 significantly expands the scope of RoHS-1 and the obligations of the EEE companies. Additional requirements relate to the conformity assessment procedure, CE-marking and market surveillance; importers and distributors also have increased obligations.

Being a directive, RoHS-2 must be implemented into national law before becoming binding and enforceable. National law also designates the authorities responsible for verifying compliance and sets sanctions for violations.

REACH: The REACH Regulation (Regulation 1907/2006) is aimed at improving chemical management and increasing chemical safety. It applies not only to chemicals in bulk, but also to chemicals in products, such as EEE, that are manufactured in the EU or placed on the EU market (plus Lichtenstein, Norway and Iceland). REACH has broad potential impact on EEE, and EEE importers and producers should know what substances are present in their EEE and the obligations REACH imposes. REACH sets forth requirements regarding (i) information and notification, (ii) registration, (iii) authorization, and (iv) restriction of substances in EEE. Being a regulation, REACH is directly enforceable in all Member States, without the need for any implementation into national law. National law, however, determines sanctions and the market surveillance authorities.

 
 


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