CE, RoHS & why should you perform certification of electronic devices


Responsibilities coming from the European Union's strict environmental standards don't have to be a producers and consumers' burden, although it is treated as such by many. Here’s few reasons why they shouldn’t. 

What is RoHS certification?

The EU's RoHS directive has its roots in 2003, while in many European countries it involved a dispute over competencies. The overarching goal of the RoHS (the abbreviation which stands for Reduction of Hazardous Substances) is to reduce the impact of electronics on the environment and health. The regulations are aimed at making electronic production safer at every stage of the life cycle of an electronic device. Detailed information can be found on the website of the Chief Inspectorate of Environmental Protection.

Emerging with the increase in the production and use of electrical and electronic products, the RoHS directive is rooted in environmental concerns. When electronic equipment is used, processed or assembled, harmful substances such as lead and cadmium can be released, and consequently cause significant problems for the environment and human health. It's also not difficult to imagine the potential course of industrial accidents even when usage of these substances present undoubted benefits for the industrial and service sectors. RoHS is designed to prevent such problems. Limiting the presence of certain hazardous substances in electronic products means that it can be replaced by safer alternatives.

When the regulations were introduced, numerous EU manufacturers not only had to find those safer alternatives to the substances mentioned below, but were often forced to change designs and production methods - quite often to more expensive ones - as the regulations indicate. Even more challenges arise for producers which use more than one factory to produce different components for an EEE product. Such an entity must then be sure that:

  • One factory produces RoHS-compliant components.
  • The other factory manufactures/supplies parts compatible with these components.
  • The components are assembled properly and to RoHS-compliant specifications, with special attention to safe solder joints.

These are only some of the challenges which seem to actually be just the tip of the iceberg. An interesting case emerged in July 2020 when Nikon recalled Nikon F6 camera after finding that units sold on or after July 22, 2019 contained dibutyl phthalate (DBP). This substance stands as an endocrine disruptor banned by the Restriction of Hazardous Substances (RoHS). Produced since 2004 and once the best-selling Nikon device, it has thus become a niche product. Recall affected just over 150 cameras that were sold after the effective date of the DBP restriction. This case may be one of the few in which a reputable brand has been publicly announced as violating RoHS compliance, but that doesn't mean that RoHS enforcement is rare.

What is RoHS about and why is it important?

It’s no secret that with the rapid spread of digitization, global production of electrical and electronic equipment is exploding. This is undeniable and to conclude here is like saying nothing at all. Usually mobile devices come to mind first, but there are more - upcoming wave of IoT (Internet of Things) devices, smart home assistants, robotics both professional and amateur, drones, skyrocketing 3D printing market or even home medical devices. All of these are regulated by RoHS. The directive restricts the use of heavy metals, flame retardants and plasticizers such as:

  • Cadmium.
  • Mercury.
  • Hexavalent chromium.
  • Bis(2-ethylhexyl) phthalate [DEHP].
  • Benzyl butyl phthalate [BBP].
  • Polybrominated biphenyls (PBB).
  • Polybrominated diphenyl ethers (PBDE).
  • Dibutyl phthalate (DBP).
  • Diisobutyl phthalate (DIBP).

Companies operating in heavily regulated industries and markets know the importance of the matter represented by compliance - in terms of reputation, accountability and even financial performance, A common cause-and-effect error comes from the belief that since elements such as lead and cadmium used in electronics are trace (micrograms), so are their effects on the environment, human health and, ultimately, the costs and methods of managing such waste. In fact, they tend to "pile up" and pose a serious problem when disposed of.

RoHS certification process in 3 steps

  1. Testing. Either an on-site test, an XRF test, and/or a laboratory phthalate solvent extraction test shall be performed to determine the values of the ten RoHS restricted substances.
  2. On-site audit to check all relevant manufacturing processes used toward RoHS compliance.
  3. Documentation review. Includes a review of the bill of materials, technical documentation, assembly drawings, material declarations, test reports and certificates of compliance/compliance from suppliers.

Any company or other entities that sell individual electrical or electronic products, equipment, subassemblies, cables, components or any spare parts directly to countries covered by the RoHS, or sell them to dealers, distributors and integrators who in turn sell products to these countries, are required to develop these steps.

WEEE Directive

WEEE (short for Waste from Electrical and Electronic Equipment) is closely related to RoHS. The WEEE Directive 2002/96/EC mandates the treatment, recovery and recycling of electrical and electronic equipment, as 90% ends up in landfills. All products on the EU market must meet WEEE requirements and have a sticker with wheelie bin.

Implementation and enforcement

The effectiveness of these laws is not measured by the number of individuals and violators punished, but by the number of toxic substances that do not reach the market. Reports commissioned by the European Commission indicate that the directive has contributed to a significant decline in the use of the listed substances. This has been achieved through rigorous enforcement by authorities in EU member states and self-reporting by companies whose products and equipment fall within the scope of the directive.

The EU RoHS Directive is being actively enforced by member states, which coordinate their efforts through regular meetings of formal cooperation groups. The competent enforcement authority for a particular product is usually determined by the product's point of entry into the EU, but can also be determined by where the company is based. Regulators share information on selected industries or products, audit results and enhance the authorities' ability to detect violations and hold entities accountable. It is important to remember that each EU member country implements the RoHS Directive differently, so electronics manufacturers planning to import their products into the EU need to know not only the EU law, but also the individual methods each country uses to implement it.

In early 2022, the EU revised the directive. It's worth keeping track of these changes, because as of February 2023, less than a month before the time of writing this text, certain fluorescent lamps can no longer be marketed in the European Union, and this is tantamount to a ban on their sale. Is there a general trend that can be observed thanks to knowing the direction of change? Certainly - a further acceleration of LED market development. From each piece of information comes a different (and quite illuminative, pun not intended) one. Finally, the introduction of products that do not have CE marking or do not meet standards present a risk of really unpleasant situations - in Poland fine can be as high as PLN 100,000. The responsibility for declaring a choice as CE marked stays as a sole one of its manufacturer.

CE marking

Most of us saw it at least once. On commercial products, the letters CE (as the CЄ logo) signify that the manufacturer or importer confirms the goods' compliance with European health, safety and environmental standards. However, it is not, contrary to popular belief, a quality indicator or certification mark. The CE marking is required for goods sold in the European Economic Area (EEA), but is also found on products sold elsewhere that were manufactured in accordance with EEA standards. CE marking is mandatory for products covered by EU specifications that include a requirement for this marking. Let’s break it down further.

The CЄ mark indicates that product may circulate freely in any part of the European Economic Area regardless of its country of origin. It consists of the CE logo and, if applicable, the four-digit identification number of the notified body involved in the conformity assessment procedure. "CE" is an abbreviation of the French conformité européenne meaning European conformity. Quite simple.

Where is CE required?

CE marking is mandatory for certain groups of products for sale within the European Union, the European Free Trade Association (EFTA) and Turkey. Manufacturers of products coming from the territory of these countries and importers of goods manufactured in other countries thus confirm that goods bearing the CE mark comply with EU standards.

After Brexit, the UK government introduced the UKCA mark as an equivalent indicator of conformity, and it is required for goods that can be sold in the UK - although goods with the CЄ mark (only) can still be used until December 31, 2024. As Northern Ireland has been aligned with the European Single Market under the Protocol, the CE mark remains mandatory for products marketed there, and while the UKCA mark can be used in addition, it is not required. Goods for sale anywhere in the UK can and usually will carry both of those marks.

As of 2019, CE marking was not required by Central European Free Trade Agreement (CEFTA) countries, but members Albania, North Macedonia and Serbia and Montenegro are applying for EU membership as canditates and adopting many of its standards in their legislation. The same was true of most Central European former CEFTA member countries that joined the EU (prior to accession).

CE marked products

That’s a long list to be sure. Product groups requiring CE that may be associated with electronics include, but are not limited to, toys, active implantable medical devices (excluding surgical instruments), appliances that burn certain types of gas fuels, devices that use electromagnetism, protective systems intended for use in potentially explosive atmospheres, heating boilers, radio equipment or measuring devices. Detailed information, documents, useful listings and links can be found on the official website of the European Union.

Electromagnetic compatibility (EMC)

It is worth pointing out one aspect of CE that is particularly important because it is often encountered in electronics, in the broadest sense. EMC-compatible devices do not interfere with their own operation or that of other devices in the context of interference, and are immune to the emissions of other devices, as long as those devices meet EMC guidelines. Based on Directive 89/336/EEC having its foundations in 1989, Directive 2014/30/EU regulates electromagnetic compatibility especially in the context of radio communications.

The buzzwords under which we recommend you look for supplemental information are:

  • Electromagnetic emission testing.
  • Electromagnetic compatibility (CE, EMC).
  • Design of electronic devices and CE.
  • RED certification - radio.
  • RF - certification of radio devices.

A little boast on the phenomenon of electromagnetic emissions. We can read that The World Health Organization WHO, based on an analysis of the results of more than 25,000 scientific studies, has concluded that "there is no sufficient evidence of the negative health consequences of exposure to electromagnetic fields generated by telecommunications equipment". Opinions on issues such as microwave radiation, ELF radiation and so-called electromagnetic smog (electrosmog) seem to irrevocably divide even the scientific world in half, and many of the factors described are considered possibly carcinogenic to humans or insufficiently classified

It is not difficult to look for examples of public resonance far louder than the mere potential impact of EM field on the environment and health - one need only look back to the turmoil associated with demonstrations against the 5G mobile network across some European countries. Attempts to discuss the topic in a consumer-friendly manner seem, according to many, to be heavily characterized by marketing language and oversimplification, while lobbies opposing such solutions are often based on statements of at least questionable credibility. Regardless of anything mentioned above, this can only mean one thing for designers, prototypers and manufacturers of electronics - the need to keep an eye on changes in legislation. And making upgrades.

User- and producer-friendly electronics certification? Sure it’s possible

All RoHS and CE issues incorporated in the provisions of EU and national legislation are interrelated. However, no one needs to be left alone in the maze of regulations and the need for certification. When in doubt, it is worthwhile to check numerous consulting and advisory outlets that are springing up in the wave of the need to meet the standards, take advantage of advices posted on websitessuch as the government information services, share common experiences with other producers and finally rely on DevicePrototype project experience. We may not specialize in consulting on European regulations, but as responsible business entity we operate within the same rules, and our team is always able to meet the strict standards of RoHS and CE.


Oskar Pacelt