- Part-one of the Environmental Legislation Series exploring REACH
- REACH attempts to give regulatory oversight of every chemical brought into the EU
- Understand your team’s legal and ethical obligations with relation to potentially hazardous substances
You’re developing an electronic product; a vast array of chemicals are present in, and used in the manufacture of, this product. How do you know whether these substances have impact on the environment or human health? And what are your legal obligations to prevent these impacts?
This two-part series will give a crash-course on existing environmental legislation as it applies to electronics and product development teams, and practical ways to comply with these pieces of legislation. We cover the two heavy hitters in the environmental legislation world: REACH and RoHS. Also covered is California’s Prop 65, the batteries directive, and the WEEE and POP directives.
And yes, those last two sound hilarious when said together.
Let’s kick-off the series by reviewing one of the most complex and commonly misinterpreted pieces of environmental legislation: REACH.
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.
REACH – the slightly awkward acronym for the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals legislation, is very poorly understood, but has far-reaching implications for device manufacturers.
‘REACH is very poorly understood, but has far-reaching implications for device manufacturers.’
Traditionally, when manufacturers used a substance with harmful effects, governments had to prove the substance was harmful. After proving the toxicity of the substance, governments would then pass legislation to ban the use of the substance. REACH flips this on its head; if a manufacturer wants to use a new substance (or an existing substance for a new application), they must prove the substance (and the use of that substance) is safe.
REACH thus attempts to give regulatory oversight of every chemical brought into the EU, and as such, is widely described as one of the most ambitious and complex pieces of legislation in EU history.
Contrary to what many working in hardware think, REACH does not only apply to chemicals in the form we think, REACH’s reach extends beyond things with unpronounceable names in 44-gallon drums. Substances in articles (REACH terminology for components and assemblies) are also impacted by the REACH regulation.
For example, REACH restricts the use of some plasticisers common in PVC cables. Manufacturers that import articles with restricted substances can face legal and financial penalties as well as having their product removed from the EU market. Sony felt the sting when they had to replace 1.3 million cables after Dutch authorities found unacceptably high levels of cadmium in the cables. Many other examples of products being forced from the market due to REACH non-compliances exist, and random testing of products is occasionally undertaken by EU authorities. These examples make clear the imperative to understand REACH in order to successfully design products for the EU market.
Structures and Definitions
To explain REACH further, we need to outline some of the basic structures and definitions of REACH. REACH can be very confusing, so, it’s worth starting with a solid foundation.
The REACH regulation defines an article as an object “which during production is given a special shape, surface, or design which determines its function to a greater degree than its chemical composition”. The exact application of this definition is complex, but for the purposes of this post, we can say that components like resistors, screws, etc. are generally considered articles. A circuit board is a complex object made up of many articles (components, plastics, etc.), as well as substances (which are chemical elements and thier compounds, such as solders, glues, fuels, dyes, solvents, metals, etc.).
REACH applies to substances as well as substances in articles. An article such as a cable may contain a listed substance as part of the chemical makeup of the insulating plastic, in which case, there would be obligations implied under REACH. REACH denotes substances that exceed toxicity or bioaccumulation limits – i.e. substances that are generally harmful to human or environmental health, as Substances of Very High Concern (SVHC). The European Chemicals Agency (ECHA) maintains three lists of Substances of Very High Concern (SVHCs).
These lists progressively escalate in concern and required obligations under REACH:
- The Candidate List of Substances of Very High Concern for Authorisation (also known as Candidate List): the ‘initial watch list’ for REACH. Substances on this list are candidates for further regulation under REACH. The general idea is that substances on this ‘watch list’ are eventually moved onto one of the other lists.
- Authorisation List: substances on this list cannot be imported into the EU unless authorisation is obtained from ECHA. Note that this only applies to substances, it does not apply to substances in articles. Authorisation is required regardless of quantity used. This is denoted in REACH terminology as the substance being subject to authorisation obligations.
- Restricted List: substances on this list cannot be used except as per the conditions in the list entry for that substance. This is denoted in REACH terminology as the substance having restrictions applied.
Usually a SVHC will be listed first on the Candidate List. SVHCs are usually intended to progress from this list onto the Authorised List or the Restricted List. Note that it’s a common mistake to confuse the Candidate List of SHVCs for Authorisation with the Authorisation List. The former is usually referred to as the Candidate List.
Manufacturers are disincentivised from using substances placed on any of the above lists, because of:
- obligations implied by the use of these substances, as discussed below,
- the burden imposed by manufacturing controls of these substances, as well as maintaining these records,
- the potential for future additional authorisations or restrictions on that substance; and
- potential supply chain disruptions as manufacturers and suppliers move away from SVHC substances.
Obligations Under REACH
The obligations under REACH depend on which list the substance is present on. Obligations under REACH are Communication, Notification, Registration and Evaluation, Authorisation, and Restriction obligations. We will discuss each of these in a separate section below.
Use of Candidate List substances in articles require safe use guidance and declarations of use where the following criteria are satisfied:
- The substance is on the Candidate list
- The substance is present in articles above a concentration of 0.1% by weight (‘by weight’ applies to each article individually, not the assembly as a whole)
To professional users and distributors, the supplier is obliged to communicate relevant safety information, including the declaration that the chemical is included on the Candidate List, and directions of safe use, when the article is supplied for the first time.
To consumers, the supplier is obliged to provide the relevant safety information within 45-days of the consumer requesting this information, commonly referred to as an ‘Article 33 request’.
For example, a manufacturer uses a PVC cable with Short-Chain Chlorinated Paraffins (SCCP) as a plasticiser/flame retardant. As SCCPs are on the SHVC list, the manufacturer must determine the amount of the SHVC by weight inside the applicable article – in this case, the cable. If the weight of SCCP chemical present in the cable is >0.1% of the cable weight, the communication obligations to consumers, professional users and distributors apply as described above.
Refer to  for further information on communication obligations.
Suppliers are required to notify ECHA of use of Candidate List substances in articles where:
- The substance is present in articles above 0.1% by weight (‘by weight’ applies to each article individually, not the assembly as a whole)
- The substance is imported in quantities in aggregate of 1 ton/year
- The substance is expected to be exposed to humans or the environment under ‘reasonably foreseeable conditions of use, including disposal’
- The substance is not already registered for that particular use
The last two conditions mean that equipment manufacturers rarely have notification obligations under REACH. Manufacturers where these conditions apply should seek professional counsel to understand their obligations.
Registration and Evaluation
Registering chemicals for use with the ECHA, and investigating these chemicals for that particular use, only apply to those importing substances (i.e. they do not apply to those importing substances in articles). Put simply, if your product has an intentional release of chemicals (e.g. printer cartridges, scented items, antibacterial wipes etc.), or contains lubricants, gels, etc., then you will need to understand your responsibilities with regards to Registration and Evaluation. These are not detailed here for the sake of brevity.
The Authorisation process generally only applies to substances; “authorisation is not required if the substance is imported into the EU as an integral part of the imported articles”. Companies manufacturing finished articles in the EU will need to understand their obligations, for example, the solder paste used in circuit assembly may be subject to authorisation requirements.
If your product has an intentional release of chemicals (e.g. printer cartridges, scented items, antibacterial wipes, etc.), or contains lubricants, gels, etc., then you will need to understand your responsibilities with regards to Authorisation. These are not detailed here for the sake of brevity.
This is the big one for equipment manufacturers – the restricted list. Basically, if any of your articles contain a SVHC on the Restricted List, you will need to review the conditions of restrictions for that SHVC and ensure you don’t violate any of those conditions. See  for the full list.
For electronics manufacturers, relevant restrictions include Cadmium, Lead, Polybrominatedbiphenyls (PBB), Phthalates (DEHP/DBP/BBP/DIBP), Polychlorinated Triphenyls (PCTs), among others. Restrictions can also apply to electronics in roundabout ways, for example, nickel has restrictions when used in contact with skin.
‘Restrictions can also apply to electronics in roundabout ways, for example, nickel has restrictions when used in contact with skin.’
Many restricted chemicals relevant to electronic equipment are also covered by the RoHS regulation, which will be covered in our next post. However, the REACH Restricted List is updated annually, so manufacturers should keep an eye-out to ensure they are compliant with any updates.
Practical REACH Compliance
No certification is required for REACH compliance, which leaves the acceptable testing strategy, and thus the acceptable risk of non-conformance, up to the equipment designer or manufacturer. Note that legally, the responsibility rests with the company importing into the EU. Generally, as most supply-chains are poorly understood and controlled, companies will seek to minimise risk of non-compliance to an acceptable level, as understanding the exact chemical composition of every part of your equipment is generally unpracticable.
Confidence in REACH compliance is commonly established by one of two strategies: the ‘lab testing’ approach and the ‘document collation’ approach.
In the ‘lab testing’ approach, a sample of the product is ground and analysed for SVHC using chemical analysis such as mass spectrometry (see ). This is expensive and cumbersome, however, and is not used by most companies as a result. There are also complications with test methodologies, since by-weight limits apply to individual articles and not the assembly as a whole. However, this method can be used as a confidence-check for individual articles of concern or for critical components.
In the ‘documentation collation’ approach, companies obtain REACH supplier declarations for each item on your BOM.  shows a good example of a REACH declaration from AlphaWire: the declaration clearly states that no Candidate List SVHCs are present in excess of 0.1%; it clearly states that no products contain Article 67/Annex XVII (Restricted List) substances; it clearly states any non-compliant parts and the SVHCs used inside; and the REACH list used is dated (versioned).
Documentation can be quite time-intensive to collate and request, however, and may not be available for some products, especially those supplied by smaller/overseas suppliers. A ‘risk-reduction’ approach can be accomplished by narrowing-down the range of components requiring documentation used in the product, then asking suppliers of these components for REACH compliance declarations.
For example, SVHCs are commonly present in plastics and plastic insulation in electronic products. An acceptable risk reduction strategy may be to use only RoHS-compliant products, and get REACH declarations only for components likely to contain SVHCs.
REACH compliance-checking services such as BOMCheck.net and GreenSoft can be used, though these are generally more useful for larger companies with established compliance or component engineering teams. You can also reach out to your contract manufacturing partners, many of whom are able to evaluate REACH compliance as a service.
With environmental legislation constantly changing, manufacturers are becoming 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 to the environment and having major implications to 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 & Further Reading
2. Enforcement of RoHS, REACH and POPs substance restrictions across Europe
3. Substances restricted under REACH
4. Guidance on substances in articles, ECHA
5. REACH Compliance: What you need to Know – Assent Compliance
6. BOMCheck: Guide to REACH Requirements for component suppliers and equipment manufacturers
7. Where are REACH SHVCs in electronic components and parts?
8. AlphaWire REACH Compliance Statement