RoHS Recast: Is My Product Affected?November 4, 2015
RoHS, an acronym for Restriction of Hazardous Substances, is a directive originated in the European Union and was first brought into force in July of 2006 (RoHS 2 FAQ 28). The objective of this program is to regulate the concentration of six hazardous chemicals contained in electrical and electronic equipment (EEE). The substances included are Lead, Mercury, Cadmium, Hexavalent Chromium, Polybrominated Biphenyls (PBBs), and Polybrominated Diphenyl Ethers (PBDEs). Cadmium may not exceed a concentration of 0.01% by weight in any homogenous material, while all others may not exceed 0.1% by weight (DIRECTIVE 2011/65/EU 100).
The Birth of RoHS 2
On January 2, 2013, the original RoHS directive was repealed and has been replaced by the RoHS recast, known as RoHS 2. RoHS 2 is an updated version of the first directive and is mainly aimed at preventing the risks these hazardous substances pose to “human health and the environment, with a particular focus on workers involved in the management of electronic waste,” which is greatly increasing in volume in the European Union. It has been determined that the best way to address these concerns is to control the use of hazardous substances during the manufacturing process (RoHS 2 FAQ 5-6).
RoHS vs. RoHS 2
There are a few important differences between the first RoHS and RoHS 2. Among those differences is a gradual extension of RoHS requirements to all EEE by July 22, 2019, including all cables and spare parts (with some exclusions). Starting on July 22, 2014, Category 8, Medical Devices, and Category 9, Monitoring and Control Instruments, two new product categories that were previously exempt, will be introduced. Another significant difference between RoHS and RoHS 2 affects product marking requirements. Previously under the first RoHS directive, manufacturers would use the following markings, among others, to demonstrate compliance of their product:
Now, under RoHS 2, all EEE within scope must be CE marked. The CE mark, which stands for European Conformity, symbolizes that the responsible party has completed all appropriate compliance procedures for that product. As of January 2, 2013 the CE mark is the only mark that can be used to indicate RoHS 2 compliance (RoHS 2 FAQ 5-6).
Does RoHS 2 apply to my product?
All of that being said, the question still lingers: “Does RoHS 2 apply to my product?” To decide, you must first determine if your product is EEE as defined in Article 3(1) and Article 3(2). Per the directive, EEE is “all equipment that has at least one intended function which is dependent on electric current or electromagnetic fields, or that generates or transfers or measures such currents and fields…” (RoHS 2 FAQ 19-20).
You may be wondering, are circuit boards considered EEE? “This depends on whether the board is placed on the market as a finished EEE product…, or it is placed on the market as a component for further production or integration in to a finished EEE product.” If the latter is true, then RoHS 2 provisions are not applicable. However, any item sold for direct use by the consumer is considered EEE. Empty, or bare, circuit boards with no components are not deemed finished EEE (RoHS 2 FAQ 18).
If your product does not meet the definition of EEE, then the provisions of RoHS 2 do not apply.
Wait! Your product may be exempt.
If your product does fall within the classification of EEE, there are additional determinations to be made. You must now ask yourself if your product falls within any of the categories excluded by RoHS 2 as specified in Article 2(4). Some of these exempt categories include military/security equipment (e.g., missiles), equipment designed to be sent into space (e.g., satellites), means of transport (e.g., cars, commercial aircraft, trains, boats), active implantable medical devices (e.g., pacemakers), photovoltaic panels, and R&D equipment. If your product falls in one of these categories, then the provisions of RoHS 2 do not apply (RoHS 2 FAQ 16-17).
If your product cannot be classified into an exempt category as listed in Article 2(4), you must now decide if any substance exemptions can be applied. In some cases, an exemption can be granted and the specific use of a hazardous substance can be justified based on certain criteria. Under the first RoHS initiative, exemptions could be granted based on overall practicability. Meaning if the result of using the substitute would be more negative to environmental and consumer safety than the use of the restricted substance, an exemption could be warranted. In addition to these parameters, RoHS 2 has also taken into account the availability and attainability of substitutes, as well as the socio-economic impact of substitution. When an exemption has been applied for, it is decided on a case-by-case basis. “Exemptions are granted for specific substances used in specific applications and not for the whole EEE, nor for a company. Therefore, whoever uses the substances in the specific application can benefit from the exemption” (RoHS 2 FAQ 25-26). As the export.gov webpage entitled, “Restriction of Certain Hazardous Substances” brings out, “these exemptions are temporary and reviewed at least every four years.”
If substance exemptions apply for your product, all provisions of RoHS 2 apply with the exception of those exempt substances. If no exemptions apply, then all provisions of RoHS 2 are applicable.
RoHS applies to my product. Now what?
So, you have determined that RoHS 2 applies to your product. Now what? There are still some important points to keep in mind before you begin testing your product for RoHS 2 compliance. If your EEE product consists of different components, it “can only meet the substance requirements if all components and parts meet the substance restriction requirements of RoHS 2, including non-electronic or non-electric components” such as bolts, wires, or plastic cases (RoHS 2 FAQ 25-26).
Each material in your product must be separated into homogenous samples and tested individually to determine full compliance. “A homogenous material is either a material with a uniform composition throughout, or a material that consists of a combination of materials” that cannot be mechanically separated in any way. In addition, it is also important to know that RoHS 2 restrictions do not apply in the manufacturing process; therefore, restricted substances can be used during production, as long as the finished EEE product does not exceed the set maximum contamination limits (RoHS 2 FAQ 27-28).
If your product currently contains restricted substances and your company needs to transition into RoHS 2 compliance, it may be necessary to perform other types of testing during this process. This will help to ensure that your product maintains the same level of quality and performance.
If your product is destined for sale in the European market, RoHS 2 should be an integral part of your quality program moving into the future. By July 23, 2019, unless your product falls into an exempt category, RoHS 2 regulations will directly affect every electrical and electronic equipment manufacturer (RoHS 2 FAQ 9). For that reason, it is encouraged to begin testing your product, and all its components, for RoHS 2 compliance as soon as possible.