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RoHS Overview

Restrictions on Hazardous Substances (RoHS) Overview

RoHS’s (Directive 2011/65/EU) requirements for internal process controls and technical documentation require that good business practices be in place across all functional departments to demonstrate continuous compliance over the entire life cycle of each product.

FOCUS OF THIS OVERVIEW: The impact of the EU’s RoHS directive on:

  • Product manufacturers who place on the EU market products that are within the scope of RoHS

  • All-sized suppliers who provide materials, components and/or assemblies to the product manufacturers who place product on the EU market

What you need to know

What you need to watch for

Legislative History

Geography/Markets

Liability

How RoHS impacts companies

RoHS Requirements

RoHS Risks

RoHS Enforcement

 

What You Need to Know

  • RoHS targets electrical and electronic equipment (EEE): essentially, any product with a battery or plug except for exempted products outside its scope

  • Commonly referred to as RoHS2, the RoHS directive today is a substantially-different, updated version of the original directive

  • The differences between the original RoHS directive and RoHS2 are substantial and should not be over-looked by OEMs and suppliers seeking to minimize, if not eliminate, their financial risks from both legal liabilities and business risks

Major Differences in RoHS-Restricted Substances Between RoHS and RoHS2

  • Original RoHS targeted 6 substances. Today, RoHS2 targets 10 hazardous substances and limits their concentrations:

  • Four additional substances, as of March 31, 2015:

    • Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %)**

    • Butyl benzyl phthalate (BBP) (0.1 %)**

    • Dibutyl phthalate (DBP) (0.1 %)**

    • Diisobutyl phthalate (DIBP) (0.1 %)**

The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.

“The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.”

“The restriction of DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006.’”

Source: http://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=CELEX:32015L0863&from=EN

  • Other substances will likely be added to RoHS2 in the future
  • RoHS’ basis for compliance is at the homogenous material level – not the fully-assembled product, i.e. each material in every component in a product must be RoHS complaint

Major Changes in Scope between RoHS and RoHS2

  • Annex 1 is new: Categories of covered EEE are defined in the RoHS Directive itself (instead of referring back to the Waste Electrical and Equipment directive)

    • Category 8 equipment is now included:

      • “Medical devices” - effective July 22, 2014

      • “In-vitro medical devices” – effective July 22, 2016

    • Category 9 equipment is included:

      • “Monitoring and control instruments” – effective July 22, 2014

      • “Industrial monitoring and control instruments” – effective July 22, 2017

    • Category 11 equipment is a new category:

      • “Other electrical and electronic equipment” not covered by any of the other categories – effective July 22, 2019

    • Open Scope for RoHS: Covers all EEE except that which is specifically excluded in Article 2(4)

      • Excluded EEE

        • Military equipment

        • Equipment sent into space

        • Large-scale stationery industrial tools

        • Large-scale fixed installations

        • Means of transport for persons or goods (except two-wheel vehicles)

        • Non-road mobile machinery exclusively for professional use

        • Active implantable medical devices

        • Photovoltaic panels producing energy in a fixed location

        • Equipment used only for research and development

Major Changes in the Exemption Process Between RoHS and RoHS2

  • Annex III is the same as the original Annex: Exemptions that are not specific to “medical devices” or “monitoring and control instruments”

  • Annex IV is new: Exemptions that are specific to “medical devices” or “monitoring and control instruments”

  • Annex V is new: Application information required for a new exemption or to renew an existing extension

  • Expiration dates will now be assigned to all exemptions:

    • 5-year maximum for Categories 1 – 7 or 10 – 11 exemptions

    • 7-year maximum for Categories 8-9 exemptions

  • Exemptions must be renewed via the following process:

    • Applications must be filed 18 months prior to expiration

    • European Commission must issue its decision 6 months prior to expiration

 Major Changes in Compliance Between RoHS and RoHS2

  • Module A is new:

    • Manufacturers must demonstrate compliance per Decision 768/2008/EC, Annex II by maintaining technical documentation, citing relevant harmonized standards, implementing internal production controls, and keeping a register of nonconforming products

  • CE mark is new:

    • Finished product must display CE mark, manufacturer's name, trademark, contact address, and type/batch/serial number (to facilitate recalls)

  • EC declaration of conformity is more rigorous:

    • Must "accompany" the finished product, must contain elements listed in Annex VI, and must be in the language or languages required by the Member State on whose market the product is placed

  • EEE not manufactured in the EU must have an EU importer:

    • Both manufacturer and importer are legally responsible for compliance

What You Need to Watch For

  • A surge in customers requiring suppliers to provide quality data along with quality materials and products, in order to help them comply with ROHS2. This requirement will likely become a condition of winning business and of receiving payment

  • Further expansion of products within the scope of RoHS

  • Expiration dates for existing exemptions that your company is relying on for products to be compliant

  • Additional changes in the process when applying for a new exemption or for renewing an existing exemption

  • Additions to the list of RoHS-restricted substances

  • As chemical manufacturers reduce or eliminate their production of RoHS-identified substances, the costs for materials using those substances may rise significantly

  • CE compliance: products must comply with RoHS and any other applicable regulations or directives which require the CE mark before the CE mark can be placed on a product

Legislative History

  •  Original RoHS (2002/95/EC)

    • Enacted: February, 2003

    • Entered into force: July, 2006

    • Repealed: January 3, 2013

  • RoHS2 (2011/65/EU)

    • Official publication: July 1, 2011

Geography / Markets

  • Primarily: European Union + 3 other nations (Iceland, Lichtenstein and Norway) that comprise the European Economic Area

    • Commonly, if inaccurately, referred to as the “EU”

  • Additionally: Localized “RoHS-like” regulations in California, China, Korea, Turkey and other countries. These laws require attention from companies placing products on any of those markets.

Liability

  • Legal liability: Companies located within the EU, as defined above

    • Includes manufacturing facilities of companies that are based in the US, Japan, China or other non-EU nations, if those facilities are legal entities in the EU

  • Business liability: regardless of location, all companies who place products on the EU market and/or supply to companies who place products on the EU market

How RoHS2 Impacts Companies

  • Places manufacturers of materials, components, assemblies and finished products (and their authorized representatives, importers and distributors) at financial risk from perceived or actual non-compliance

  • Requires manufacturers of in-scope electrical and electronics products to:

    • Reduce the concentrations of the listed substances to at or below the specified threshold limits allowed, including any applicable exemptions

    • Maintain technical documentation to verify that their products are compliant and the declaration of conformity for 10 years after the last unit of a product is manufactured

    • Implement internal production controls to ensure compliance of every unit for each product manufactured

    • Apply the CE mark for assembled products placed on the EU market

  • Compliance requires all companies within the supply chain to collaborate with each other in order to collect, verify and exchange quality RoHS-related substance data – the same process necessary for compliance with REACH, Conflict Minerals, ELV and other product substance laws

  • Imposes compliance costs that:

    • Are here to stay for the foreseeable future and must be factored into the costs of doing business

    • Are heightened when data-collection re-work is needed because 1) data-collection specialists are inadequately trained; 2) the substance data is incomplete and/or accurate; and, as a predictable result, 3) customers reject the submitted data and require updated, quality data

    • Are lowered when companies implement 1) a “Do It Once, Do It Right”® approach and 2) a Regulatory Compliance Management Process® that integrates compliance with multiple laws

RoHS2 Requirements

Requirements Summary

Type of Requirement

Companies Within Scope Must:

Limit on Substance Concentration

Not incorporate identified substances at concentrations which exceed a legally-allowable limit in any given homogenous material

CE Mark

Apply the CE mark based on RoHS2-compliance before placing products on the EU market

Technical documentation

Be able to present a technical file to enforcement authorities (or customers) that

  1. adequately analyses and assesses hazardous risks;
  2. includes designs and manufacturing drawings, as well as schematics of components, sub-assembles and circuitry; and
  3. verifies that electrical and electronic products placed on the EU market comply with RoHS2

Production control documentation

Be able to document their internal production control procedures for ensuring compliance with RoHS2 now and in the future
Non-conforming products and product recalls Maintain a register of these products and notify distributors of them
Labelling Adhere to specific labelling requirements
Corrective actions Bring non-compliant products into compliance or withdraw them from the market
Notification Notify the Competent Authority in any nation where corrective action, including product withdrawal, has occurred

RoHS Risks

RoHS2 entails a wide variety of legal and business risks for all companies within a supply chain.

While attention is typically focused on legal risks, the greatest non-compliance impact on companies may very well result from business risks, e.g.:

  • A customer cancels a contract or delays placing your products on the EU market until you provide substance documentation

  • A competitor provides substance documentation earlier than your company does, and it uses that documentation to win new customers and to take away your existing customers

  • As chemical manufacturers phase out EU-identified toxic substances, you may pay higher costs for those substances

  • Do-not-design notices regarding non-RoHS compliant electronic components that are being phased out must be tracked and managed to insure that replacements are found, new designs do not incorporate such components and any end-of-life purchases are sufficient to meet anticipated manufacturing demand for existing product lines

  • You may face re-design and testing costs for alternative components to replace those being eliminated by manufacturers

RoHS Enforcement

  • Under RoHS2, authorities in each EU Member State enforce RoHS2

  • Enforcement decisions may be based on any of the following:

    • Market intelligence

    • Random selection

    • Products known to contain materials of high concern

    • High volume products

    • Short life products

    • Consumer products unlikely to be recycled

    • Notification of concern from external parties

    • Notification of concern from other Member States

  • Practically, customers will enforce RoHS2 on their suppliers by requiring materials, components and sub-assemblies that are RoHS2-compliant

  • Most likely products to be scrutinized: high-volume consumer items

DISCLAIMER: This Overview is not intended to include every nuance of the RoHS Directive (Directive 2011/65/EU). RSJ Technical Consulting does not take any responsibility for the completeness of the information. Additionally, RSJ Technical Consulting does not take any responsibility for how individuals, companies and organizations may use this information or for any aspect of RoHS’s impact on their business. Individuals, companies and organizations are advised to consult their Legal staff and/or to seek third-party assessments of RoHS’s impact on their business.