Environmental Legislation: A Crash-Course in Compliance

Practical knowledge for navigating RoHS, Prop 65, and the Batteries, WEEE, and POP Directives.
  • Part-two of the Environmental Legislation Series
  • Legal obligations and practical compliance for RoHS, Prop 65, and the Batteries, WEEE, and POP directives
  • Develop for strict environmental requirements in the EU and US

When developing a product, how do you know whether substances present in, and used in the manufacture of this product have a negative impact on the environment or human health? And what are your legal obligations to prevent these impacts?

Part one of the environmental legislation series provided information to electronics and product development teams about REACH. This next installment rounds-out the series by reviewing other environmental legislation relevant to product design teams: RoHS, California’s Prop 65, the batteries directive, and the WEEE and POP directives.

As a disclaimer – this is not legal advice, this is an engineer’s interpretation of the extremely complicated regulations and guidance and only applies to electronics and product development teams.

RoHS

RoHS, the EU directive for the Restrictions on Hazardous Substances, restricts substances that can be present in finished products. RoHS jurisdiction is limited to electrical and electronic equipment in the EU – but, similar legislation applies in many other countries. To put it simply, from both a legal and social-responsibility standpoint, any electronic product you develop should be RoHS compliant; it serves as a minimum guideline to prevent harmful chemicals being used in electronics.

RoHS is easy to achieve compliance with, as most electronic components are already RoHS compliant, and evaluating a BOM for compliance is fairly trivial.

The table below shows RoHS-restricted substances and their by-weight limits[1]:

Lead0.1%
Mercury0.1%
Cadmium0.1%
Hexavalent Chromium0.1%
Polybrominated biphenyls (PBB)0.1%
Polybrominated diphenyl ethers (PBDE)0.1%
Bis (2-ethylhexyl) phthalate (DEHP)0.1%
Butyl benzyl phthalate (BBP)0.1%
Dibutyl phthalate (DBP)0.1%
Diisobutyl phthalate (DIBP)0.1%

RoHS restricts substances by weight of homogenous materials. This is defined in the legislation as ‘materials that can be (theoretically) mechanically separated’.

For example:

  • in a cable: the insulation can be stripped from the copper conductor, so the cable insulation material must comply with RoHS limits
  • on a BGA chip: the lead solder balls on the underside of the chip can be removed, so the solder balls must comply with RoHS limits
  • in an electrolytic capacitor: the plate material, the lead material, the electrolytic solution, and the casing metal must all be RoHS compliant

If only one screw in your finished assembly is not RoHS compliant, the product is not saleable in the EU. Note that RoHS-restricted substances can be used in the manufacture of the product, as long as the end-product does not contain the substance above the maximum concentration values[2].

Given this, it would be sensible to assume that a product marked ‘RoHS compliant’ does not contain any restricted substance above the applicable limit. This is incorrect though, as RoHS compliance really means compliant given exemptions; these exemptions as specified in Annex III of the directive[1].

For example, Exemption 7(a) allows lead in high melting temperature type solders; many companies use this exemption to continue using lead in the solder supplied on components. Exemption 6 allows for lead as an alloying element; this can be up to 4% by weight in copper alloys, meaning a significant amount of lead can still be present in ‘RoHS-compliant’ components. So, not all RoHS-compliant products are equally eco-friendly; different manufacturers have different levels of commitment to eliminating these harmful substances from their components. Finding ‘the most eco-friendly component’ is a complex task; reach out to us if you’d like to discuss or learn more.

RoHS has some use-based exemptions as well – including implantable medical devices, defence, photovoltaics, and some equipment used for R&D, you can see the full list here[1].

For CE marking (so a product can be sold in the EU), compliance to RoHS is required to be stated on the Declaration of Conformity[2]. The most common way to verify RoHS compliance of your product is to carry out a BOM audit, where declarations of RoHS compliance are collated for each component in the BOM.

Sometimes manufacturers can misinterpret the regulations and publish misleading declarations, though this is becoming increasingly rare. Refer to Vic Clement’s excellent article for more on the challenges of evaluating RoHS compliance[3]. At the design stage, ‘RoHS Compliant’ filters can be used on many part-search databases, though I would encourage designers to understand further the chemical content of their products, as well as any RoHS exemptions used.

WEEE Directive

The Waste Electrical and Electronic Equipment Directive[6] is part of the Extended Producer Responsibility (EPR) scheme, the EU’s attempt to put the burden of WEEE disposal and recycling back onto the suppliers of that electronic equipment. Under the directive, suppliers are financially responsible for the end-of-life of electronic equipment sold. In practice, this means that suppliers keep account of the weight of WEEE sold; this then informs the amount that is paid into a ‘WEEE compliance scheme’, which finances the collection and disposal of the WEEE. Many services and consultancies exist to facilitate compliance[4][5]. WEEE compliance is generally handled by the company that puts the product on the market in the EU[7].

The directive also requires manufacturers to mark the ‘crossed-out wheelie bin’ symbol (shown below) indelibly on the packaging, instructions, and the product itself.

Batteries Directive

Batteries contain toxic and valuable substances, and so it is important to ensure they are recycled correctly. The Batteries Directive[8] is another major part of the EU’s EPR schema. It attempts to set up a recycling framework for batteries sold in the EU. The directive functions similarly to the WEEE directive, where suppliers have to keep account of the amount of batteries sold, and pay into a compliance scheme to finance collection and recycling of end-of-life batteries. The fee for the scheme is again based on the amount of batteries sold.

The batteries directive also prevents batteries being sold that contain:

  • 0.002% or more cadmium, by weight, for portable batteries
  • 0.0005% or more mercury, by weight, for all batteries

Note that this restriction doesn’t apply to emergency systems, emergency lighting, alarm systems or medical equipment.

This prohibition, coupled with availability and environmental concerns, lead us to advise against use of NiCd batteries in any of the products we develop.

Devices are also required to be designed such that waste batteries can be readily removed, preferably by the end-user; instructions are to be provided informing the end-user of the battery type and removal procedure. The batteries directive also requires the ‘crossed-out wheelie bin’ symbol to be present on batteries and battery packaging.

Packaging Directive

The packaging directive (EU Directive 94/62/EC) is the third major relevant part of EU’s EPR schema. As with the WEEE and Batteries directives, suppliers have recycling/disposal targets set based on the amount of packaging material placed on the market. The scheme also introduces requirements for the design of packaging to maximise recovery. In addition, packaging must contain less than 0.01% of lead, cadmium, mercury, and hexavalent chromium[15]. For suppliers selling products with packaging into the EU, it is recommended to discuss compliance requirements with a specialised packaging consultant (e.g. WEEELogic, Intertek).

POP Directive

The POP directive outlines restrictions on Persistent Organic Pollutants, chemicals that remain persistently in the environment, often bioaccumulating up the food chain and causing widespread and complex environmental and human health effects. Relevant to electronic and electrical equipment, the directive restricts Polychlorinated Biphenyls (PCBs), which were once commonly used as dielectric fluids in transformers, and Hexabromobiphenyls, which was used as a fire retardant. Hexabromobiphenyls are also restricted under RoHS (they are a subset of the Polybrominatedbiphenyl group). Neither of these chemicals should be present in any component, regardless of RoHS status, as they have both been widely banned for some time.

California Prop 65

If you intend to sell products into the State of California, you should be aware of Proposition 65. The legislation, characterised by its distinct warning label, requires companies to warn users when their products can expose them to a listed chemical, over the exposure threshold, under reasonably foreseeable conditions[11]. The legislation has increasingly come under fire for over-labelling. “The massive number of warnings, due to the size of the concerned substance list and the risk of litigation, are potentially making consumers numb to the warnings. It’s hard to focus on real health risks when everything is labelled as a risk.” [10]. Litigation against companies that don’t label their product is becoming increasingly common, especially for device manufacturers. Depending on the market, companies may suffer sales penalties for a labelled product, so it is important to understand when labelling is required.

Image: [9]

Prop 65 describes ‘Safe Harbour Numbers’ for many chemicals on the list; if the user’s exposure occurs at or below this level, the product does not need a warning[12]. Exposure is a vague concept, however, and depends on many factors; for example, “concentration of the substances at the surface of a product that may be accessible to a user; how, and how long or often, the user is exposed to that surface in the course of a day, and how readily the substance is released from that surface”[13]. Fortunately, many of the components in electronic devices are inside enclosures, and consumers cannot come into contact with them.

Mike Kirschner, in his excellent article on Prop 65 for Electronics Manufacturers, describes how exposure can result from handling or proximity to products. This then leaves the question of how much exposure occurs from exposed surfaces containing Prop 65 chemicals.

The basic ‘when to label’ strategy looks something like this:

  1. Determine whether exposed surfaces of the product contain any Prop 65 chemicals, either by:
    • Seeking Full Material Declaration (FMD) from Suppliers, then comparing this to the Prop 65 list (recommended)
    • Compiling supplier declarations that components do not contain any Prop 65 chemicals (not recommended)
  2. If Prop 65 chemicals without a listed Safe Harbour Number are present, the product must be labelled (unless the company wishes to launch a study to demonstrate the chemical exposure level is not harmful)
  3. If Prop 65 chemicals with a listed Safe Harbour Number are present, determine whether to label the product:
    • If sales volumes in California are sufficient, a toxicologist consultant can be employed to determine exposure levels  – this depends on concentration, use cases, etc.
    • Else it may make business sense to simply label the product as a precaution

Prop 65 is certainly a burdensome piece of legislation. As a practical measure, it is recommended to hire a specialised consultant to navigate the complexities of Prop 65 if selling into California.

Summary

Environmental responsibilities for manufacturers are a complex web of rules that are constantly changing. With this constant change, manufacturers are becoming increasingly incentivised to understand the chemical composition of their products. Many non-compliant products exist in the market today, which can end up leaching seriously harmful chemicals into the environment and having major implications on human health.

Put simply, it’s a moral obligation to understand what’s in the product that you make. Understanding what’s in your product also has enormous benefits: you can design-out components that are targets of future regulations, and you are prepared for any future changes in regulation. You can proactively minimise the environmental impact of your product as part of your Corporate Social Responsibility, leading to massive marketing advantages in the new sustainability-conscious economy

Want to discuss or learn more? Reach out to Exa Product Development – contact or connect with us!

References

1. RoHS Directive 2011/65
2. RoHS FAQ, European Commission
3. Electronics Weekly
4. ec4p.com
5. Ecosurety.com
6. WEEE Directive 2012/19/EU
7. WEEE Responsibilities
8. Batteries Directive 2006/66/EC
9. ABC.net
10. epsnews.com
11. Proposition 65 List of Chemicals
12. What are Safe Harbour Numbers? California OEHHA
13. California Proposition 65 for Electronics Suppliers and Manufacturers
14. Packaging and Packaging Waste
15. EU Directive 94/62/EC (Packaging and Packaging Waste Directive)

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