RoHS Enforcement

During May 2006, the Commission published a “RoHS Enforcement Guidance Document” developed by the EU RoHS Enforcement Authorities Informal Network. Its purpose is to assist member states national enforcement authorities with the interpretation of the RoHS Directive, and demonstrate to equipment producers the level and format of compliance information the authorities are likely to expect.

It should be noted, however, that this guidance document has no legal authority.

The RoHS Enforcement Guidance Document can be downloaded here.

What follows is a summary of the key elements of the document, with additional guidance and interpretation. We make no apology for the length of what follows and hope you find it informative. If, having read the RoHS Enforcement Guidance Document, things don’t get a whole lot clearer, or you still have uncertainties or questions relating to the legislation, please contact us.

Key issues addressed within the Guidance include:

• The underlying principles that might be used to guide RoHS enforcement
• The type of documentation that ‘producers’ (within the specific definition given in Article 3 of the Directive1) might be advised to keep
• The ways in which Member State enforcement authorities might use such documentation to check for RoHS compliance
• The ways in which sample preparation and analytical testing might be employed to avoid inconsistent enforcement decisions between Member States

SECTION 1: Introduction

Aims & Objectives of this Guidance

The RoHS Directive (2002/95/EC) does not prescribe any requirements in respect of compliance documentation that needs to be maintained or enforcement procedures that need to be undertaken. As a result, this document has been developed to provide non-binding guidance on these issues.

This document has two primary intentions: -

• to assist Member States with national enforcement of the RoHS Directive; and
• to provide clarity to industry on how producers may demonstrate compliance with its requirements.

Comment

Producers must be able to demonstrate compliance by submitting technical documentation or other information to the enforcement authority on request and retain such documentation for a period of four years after the EEE is placed on the market. Unlike the WEEE Directive, RoHS has no formal pre-registration or labelling requirements.

Principles

An effective RoHS compliance and enforcement regime should be based on the following underlying principles:

• a consistently applied and common interpretation across Member States regarding those products which are considered to fall within the scope of the RoHS Directive
• a presumption that products falling within the scope of the Directive conform with its requirements; and
• self-declaration by producers.

These principles will provide an effective and cost-effective approach for both Member States and ‘producers’ (within the terms of Article 3 of the Directive), who place electrical and electronic equipment on the EU market after 1 July 2006.

Comment

Again, there is no requirement to register to prove your products comply with RoHS. The act of placing products that fall within the scope of the legislation on the [EU] market automatically assumes compliance with the Directive.

This guidance document does not clarify the interpretation of ‘put on the market’ (POTM), which Belgium, Czech Republic, France, Ireland, Latvia, Lithuania, Poland, Portugal and Spain have incorrectly interpreted as put on their national markets, which is incompatible with the single market principal.

Enforcement Process

Faced with the very wide range of products covered by the RoHS Directive, Member State enforcement authorities must - in the first instance - decide which EEE (electrical and electronic equipment) categories and products they wish to select for further investigation. These decisions will be made following market surveillance activities and could involve one or more of the following criteria:

• 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.

Comment

The enforcement authorities across all 25 EU member states will not have a limitless budget the police the Directive; therefore selective targeting will be used to verify the compliance status of those products considered to have the greatest impact on the environment and human health.

Products more likely to be investigated:

Mobile phones, kettles or MP3 players built in very high volumes, which are easy to discard or are rarely recycled. The cost and size of such products would make it tempting to simply thrown them away when they fail, thus entering the domestic waste stream and thereby ultimately ending up in land fill.

Products less likely to be investigated:

Specialised, high value electrical power tools. This equipment may be sold in relatively small volumes and due to its initial cost, is more likely to be repaired should it fail prematurely, thereby reducing the need for recycling or recovery in the short term.

Complex, high value network infrastructure equipment. Very high value equipment with a long service life, which may be extended by its potential for upgrade as opposed to replacement.

Note: Telecommunications infrastructure equipment does fall within the scope of the RoHS Directive (WEEE category 3), though limited substance exemptions apply.

What might be considered ‘high volume products’? The imminent Energy using Products Directive (EuP) 2005/32/EC suggests volumes of more than 20,000 units entering the EU market each year pose a potentially serious environmental impact. As RoHS, WEEE and EuP Directives share similar fundamental principals, one could argue this figure could be used as a benchmark, though precise details are unclear at this stage.

Market intelligence’ could be interpreted as ‘whistle blowing’, an enforcement strategy we predicted early in the development of the legislation.

SECTION 2: RoHS Compliance Documentation

Figures 1 and 2 (comment: see original RoHS Enforcement Guidance Document) show a common market surveillance methodology that has been designed to assist Member States with their national enforcement of the RoHS Directive. Whilst the overall approach to RoHS compliance is based on a Presumption of Conformity, it is recognised that national authorities will require self-declaration from producers as the key principle underlying the enforcement process.

Figure 1 demonstrates a step-by-step approach to RoHS compliance investigations - initial self-declaration; followed by a more detailed assessment in those cases where evidence from producers does not assure compliance. In cases of concern, detailed sampling and testing may or could be required.

The proposed enforcement process provides two initial routes to self-declaration, taking into account that for some organisations (small and medium-sized enterprises in particular), the process may be facilitated by the initial provision of compliance documentation for homogeneous materials in products/parts (Route B in Figure 1).

However documentary evidence of more structured internal systems (based on quality assurance processes) could be the initial step in assessing a producer’s ability to manage RoHS compliance for those companies or organisations that have such systems in place. This is shown as Route A.

Figure 2 shows a step-by-step approach to enforcement action should this become necessary.

Comment

What might a self-declaration consist of? For a producer to simply state their product complies with RoHS is obviously not sufficient, so what is required? Based on the paragraph above, we have taken the route a small or medium sized enterprise (SME) would be expected to adopt, as only larger OEM’s will generally have the resource and skills to employ a high-level compliance assurance system.

Basic Documentation should include:

Contact information

Point of contact within the organization that will deal with the RoHS enforcement request.

Company information

This should include the size of the organization, product range and approximate levels of sales.

Approach to compliance

This should be a general overview of any compliance systems that the company has in place and which are suitable for assisting compliance with the RoHS Directive.

An overview of the data quality systems, (in those cases where the producer relies significantly upon supplier information to demonstrate compliance)

This could include risk assessments, acceptance criteria, purchasing procedures and any other relevant documentation and may be a combination of both process-based and product/part-based documentation.

This should be supported by:

Product/Part-based Technical Documentation

(Typical information relating to a product’s/part’s physical attributes that ensures RoHS compliance of a specific product)

Producers’ or suppliers’ warranties /certificates declaring that the use of the restricted substances is within the permitted levels.

Producers’ or suppliers’ completed materials declaration for each part (including revision for revised parts) and justification of RoHS categorisation and use of exemptions (see http://www.pb-free.info/exempt.htm). These declarations would be limited to the list of RoHS substances, not full materials declarations.

Those who use approach B only (SMEs) must also provide evidence that procedures are being followed to show that materials declarations have been assessed to determine if they can be trusted. Enforcement authorities will also need to see documented compliance procedures.

Analysis report for homogeneous materials in parts/components, (which could be the producers or suppliers own internal or external test results). The test results should refer to homogenous materials in parts/components.

However, there is no legal requirement for a detailed laboratory analysis to be performed, as section 3 of the guidance document confirms:

“Generally speaking, the employment of testing (which could be either nondestructive or destructive) to verify compliance with the requirements of the RoHS Directive will usually be seen as a last resort. In order to obtain conclusive proof of a product’s compliance the RoHS Directive, producers may however choose to carry out analytical testing of homogeneous materials in their products and/or specific components. Enforcement authorities may also choose to carry out such testing to verify the claims of producers in relation to equipment placed on the EU market.”

These documentation requirements, and the additional evidence of the control of a Compliance Assurance System (CAS), are fundamental elements of our Impact Assessment service

Evidence that the system is being followed including results of product specific conformance assessments comprising items such as product assessments (including justification of RoHS categorisation and use of exemptions), materials declarations, procurement, inventory and production controls and substance analysis where appropriate.

SECTION 3: Sampling and Testing Issues

Harmonized Approach for Sample Preparation and Analytical Testing

Generally speaking, the employment of testing (which could be either nondestructive or destructive) to verify compliance with the requirements of the RoHS Directive will usually be seen as a last resort. In order to obtain conclusive proof of a product’s compliance the RoHS Directive, producers may however choose to carry out analytical testing of homogeneous materials in their products and/or specific components. Enforcement authorities may also choose to carry out such testing to verify the claims of producers in relation to equipment placed on the EU market.

Sampling - The Challenge for Electronic Products

A typical electronic product is made up of hundreds of individual components, such as integrated circuits (ICs), discrete components (resistors, capacitors, diodes, etc), wires, cables, printed circuit boards, connectors, fasteners, sensors, enclosures etc. Each of these components has a unique mix of materials that makes up its composition. An integrated circuit, for example, may consist of a silicon die, die attach material, epoxy underfill, mould compound, leads, and lead plating materials. These materials are often heterogeneous, being themselves made up from a range of materials. Obtaining a representative sample of such a device for testing purposes can be challenging.

Comment

Producers have had to overcome numerous technical, financial and logistical challenges to bring RoHS compliant equipment to market. It is rather ironic that the enforcement authorities will face similar challenges in actually confirming compliance.

Screening

As a first step, producers and enforcement authorities may choose to use a screening tool, such as energy dispersive x -ray fluorescence (ED-XRF) analysis. This tool has been widely promoted as a simple low cost analysis technique, but the results may only give an indication that a particular product/component may or may not present a potential compliance problem. It may not, for example, be sufficient to discount the possibility of an infringement of the RoHS requirements where one or more of the substances are present in both an exempted and restricted application. It will also not differentiate different types of brominated flame-retardants or identify the valence state of chromium.

The limitations of XRF techniques must be understood and taken into account. In general bench-top laboratory systems provide greater accuracy and the ability to analyse smaller areas (<0.5 mm2) than handheld units. In either case the use of a standardised protocol based on suitable test procedures (and using certified reference materials to show correct application where possible) by a trained operator is essential. Further guidance is not provided here as both standards and instrumentation are developing rapidly.

Comment

There is currently no single analytical technique that can determine the presence of all six RoHS restricted substances at their maximum tolerated values. Moreover, it is vitally important that qualified and experienced technicians perform analytical tests to ensure the accuracy, and potential limitations of such investigations.

The document does touch upon some interesting points. For example, a semiconductor from within network infrastructure equipment is permitted to contain lead (Pb), at any concentration on its termination finish (or second level interconnect). This would obviously show up under XRF analysis, but would not automatically be discarded as an exempt application.

Sampling Strategies

As a typical electronic product may be made up of hundreds or thousands of homogeneous materials, complete testing of the product is usually impractical due to cost, time and sample preparation constraints. To address this challenge, the following three practical sampling strategies are recommended:

1. Focus on samples from known “high concern” materials and applications. It is generally not worth either the time or resource to analyse materials for substances that are not likely to be present.
2. Focus on samples that can be separated from the equipment using those ordinary tools that would be typically found in an analytical and testing laboratory or by techniques such as sectioning.
3. Where it can be demonstrated that it is not possible to mechanically disjoint a particular component or part due to its very small size or some other constraint and analysis of individual homogeneous materials is not possible, then this component or part is to be regarded as one homogeneous material. In such cases, the use of homogenizing techniques for components and parts that are composed of two or more homogeneous materials might be considered.

Comment

Following years of debate relating to the definition of homogeneous, the Commission would appear to have conceded that it might not be possible to actually separate (mechanically disjoint) components into their homogeneous constituents. However, producers should not conclude from this that subassemblies, PCB’s or even finished equipment would be measured in their finished state. It is also worth reiterating that testing will be seen as a last resort where documentation of compliance is not conclusive or complete.

Summary

This overview does not include all elements of the RoHS Enforcement Guidance Document, a copy of which can be downloaded here. Moreover, this document is informative and advisory and as such has no legal authority.

For additional help on scope, exemptions or compliance, or call +44 (0)2476 710222 to speak directly with a legislative advisor.