Restriction of Hazardous Substances Directive

Introduction

The Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU) is a key piece of European Union legislation that restricts the use of specific hazardous materials found in electrical and electronic equipment (EEE). This directive is a recast of the original RoHS Directive (2002/95/EC), expanding its scope and clarifying its provisions. Its primary aim is to protect human health and the environment from the risks posed by these substances, particularly during the waste management phase of EEE.

The RoHS Directive is closely linked with the Waste Electrical and Electronic Equipment (WEEE) Directive (2012/19/EU), which governs the collection, recycling, and recovery of waste EEE. By restricting hazardous substances at the source, RoHS facilitates safer and more environmentally sound recycling and disposal under the WEEE framework. It also complements the REACH Regulation (EC) No 1907/2006, which deals with the registration, evaluation, authorisation, and restriction of chemical substances.

Main Goal

The main goal of the RoHS Directive is to contribute to the protection of human health and the environment by restricting the use of hazardous substances in EEE. This includes promoting the environmentally sound recovery and disposal of waste EEE, thereby reducing pollution and health risks for workers in the recycling industry and the general public.

Who It Applies To

The directive applies to all economic operators involved in placing EEE on the EU market, including:

• Manufacturers
• Authorised Representatives
• Importers
• Distributors

The scope covers EEE falling into the 11 categories listed in Annex I, which includes everything from large household appliances and IT equipment to medical devices and toys.

Key Dates

• Entry into Force: 21 July 2011
• Transposition by Member States: 2 January 2013
• Phased Application: The directive's restrictions were applied in phases to newly covered product categories:
  • From 22 July 2014: Medical devices and monitoring & control instruments.
  • From 22 July 2016: In vitro diagnostic medical devices.
  • From 22 July 2017: Industrial monitoring & control instruments.
  • From 22 July 2019: All other EEE not previously covered.
• Phthalate Restrictions: Four new substances (DEHP, BBP, DBP, DIBP) were restricted from 22 July 2019 for most EEE, and from 22 July 2021 for medical devices and monitoring & control instruments.

Exemptions

The directive includes several exemptions:

• General Exclusions: Equipment for military purposes, equipment designed for space, large-scale stationary industrial tools, large-scale fixed installations, and active implantable medical devices are outside the scope.
• Specific Application Exemptions: Annexes III and IV list specific applications where the use of a restricted substance is temporarily permitted because its elimination or substitution is scientifically or technically impracticable. These exemptions are time-limited and subject to review.

Key Provisions

• Substance Restrictions: EEE placed on the market must not contain more than the maximum permitted concentration levels of the substances listed in Annex II. These include Lead (Pb), Mercury (Hg), Cadmium (Cd), Hexavalent Chromium (Cr6+), Polybrominated Biphenyls (PBB), Polybrominated Diphenyl Ethers (PBDE), and four Phthalates (DEHP, BBP, DBP, DIBP).
• Maximum Concentration Values: The maximum tolerated concentration is 0.1% by weight in homogeneous materials for most substances, and 0.01% for Cadmium.
• CE Marking & Declaration of Conformity: Manufacturers must carry out a conformity assessment, draw up an EU Declaration of Conformity, and affix the CE marking to the finished product to demonstrate compliance.

Obligations & Requirements

• Manufacturers: Must ensure EEE is designed and manufactured in compliance with substance restrictions, draw up technical documentation, perform internal production control, issue an EU Declaration of Conformity, and affix the CE mark. They must also ensure traceability and take corrective action for non-compliant products.
• Importers: Must ensure that the manufacturer has completed the conformity assessment procedure before placing EEE on the market. They must also indicate their name and address on the product and keep a copy of the Declaration of Conformity for 10 years.
• Distributors: Must act with due care, verifying that the EEE bears the CE marking and is accompanied by the required documents. They must not make non-compliant products available on the market.

Affected Products

The directive applies to all EEE unless specifically excluded. The 11 product categories are:

1. Large household appliances
2. Small household appliances
3. IT and telecommunications equipment
4. Consumer equipment
5. Lighting equipment
6. Electrical and electronic tools
7. Toys, leisure and sports equipment
8. Medical devices
9. Monitoring and control instruments
10. Automatic dispensers
11. Other EEE not covered by any of the above categories.

Penalties

Member States are required to establish rules on penalties for infringements of the national provisions adopted pursuant to the directive. These penalties must be effective, proportionate, and dissuasive.