Companies manufacturing equipment or consumer parts that use hazardous materials in the manufacturing process must comply with RoHS and REACH environment regulations. RoHS and REACH are two regulations that require compliance if a company intends to sell in the European Union, China, Korea and some parts of the United States and Canada. Therefore it is important to know which vendors possess compliance.
What are RoHS and REACH?
RoHS stands for Restriction of Hazardous Substances. Its purpose is to address the global issue of consumer electronics waste. Many electronics are disposed and end up in landfills which cause environmental and human health hazards. This directive pertains to manufacturing of various types of equipment without the use of six different hazardous materials:
Lead, Mercury, Cadmium, Hexavalent chromium (Cr6+): Used in chrome plating, chromate coatings, and primers, Polybrominated biphenyls (PBB): Flame retardant in plastic, Polybrominated diphenyl ether (PBDE): Flame retardant in plastic.
(Edit April 2018: Directive (EU) 2015/863 to amend Annex II to EU RoHS 2 (Directive 2011/65/EU) to add the following 4 phthalates onto the list of restricted substances.
- Bis(2-Ethylhexyl) phthalate (DEHP):;
- Benzyl butyl phthalate (BBP);
- Dibutyl phthalate (DBP);
- Diisobutyl phthalate (DIBP).)
For more information on RoHS compliance refer to Nigel Syrotuck’s blog on RoHS compliance.
REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals
Registration: Chemical producers are required to register safety data for all chemicals produced.
Evaluation: Experts from member states and the European Agency evaluate safety data for higher volume chemicals and other chemicals of concern.
Authorization: Chemicals that are of “very high concern” are to be phased out and replaced with safer alternative chemicals.
Restriction of Chemicals: Chemicals may be completely banned or some uses of the chemicals can be restricted.
This is a European Union regulation. The sole purpose of REACH is to address the production and use of chemical substances, and their potential impacts on both human health and the environment. REACH requires all companies manufacturing or importing chemical substances into the European Union in quantities of one ton or more per year to register these substances with European Chemical Agency (ECHA). Manufacturers, importers and also their customers are required to communicate information on chemicals throughout the supply chain in order to be aware of information relating to health and safety of the products supplied.
Some of the types of materials that are of “very high concern” include carcinogens, mutagens, reproduction toxins, persistent, bio-accumulative, and toxic chemicals
The difference between RoHS and REACH
The main difference between RoHS and REACH is that RoHS bans substances that are present in electronics and is specific to the aforementioned 6 hazardous materials. REACH, however, pertains to all chemicals including those used to make a product. This can include materials, solvents, paints, chemicals, and more.
How they work together
RoHS and REACH interact in a complex and complimentary way. If a product is RoHS compliant, it may not be REACH compliant, and vice-versa. A product may be required to meet both regulations. RoHS deals specifically with the electronics industry, while REACH is similar in design, but broader in focus.
Supplier management and qualification
It gets tricky to determine which vendors are actually compliant with these regulations and which even need to be. Some smaller vendors do not possess a QMS system and will have a limited understanding of RoHS and Reach. They might not even know what it is. Vendors might say that all of the components they receive from their manufacturers are compliant without having documentation. Or they may say that because they are REACH compliant, they are also considered RoHS compliant.
TIP: In order to ensure compliance with RoHS and REACH each vendor should send in a Confirmation of Compliance (CoC) indicating that the items in question are compliant. A CoC can be a written statement, a label or a blanket statement of compliance to a product line, material or process offered by a supplier.
No Confirmation of Conformity
If a CoC is not available, auditing a vendor or reviewing past audits is another way to ensure that the vendor is following the correct procedures.
Another option is to ask the vendor for the material declaration. The material declaration is a list of all substances in the part, product or process. This list can be compared with the specifications of RoHS and REACH. If no banned substances are present, the item can be considered compliant.
It is important that the vendor provide a written statement indicating the specifics of how each component meets the requirements for ROHS or REACH. Once the material is received it should be inspected via a first article inspection (FAI) to make sure it complies with the standard. An FAI is used to verify design features or attributes of an item. In this case it is used to verify the presence of hazardous materials.
Some vendors think that ROHS and REACH only apply to electronics
A common misconception is that both RoHS and REACH only apply to electronics themselves. While it is true the purpose of RoHS is to address growing waste created by electronic devices and the electronic industry, it is not limited to electronics specifically. Materials such as paint and pigments, PVC (Vinyl) cables, glass in television and photographic products and various metal parts in electronics should also be in compliance with RoHS requirements. The presence of the six hazardous materials is what determines RoHS compliance.
Some items may be not be evaluated for RoHS and REACH compliance. These include non-parts such digital files (code, art, text, images, etc) and space holders (e.g., to reserve space in CAD models for cable entry).
RoHS and REACH compliance are required to sell products in the European Union, China, Korea and some parts of the United States and Canada. It is important to know which vendors possess compliance. Make sure you and your vendors understand the regulations and all components have documented compliance.
Image: StarFish Medical
Taimoor Khan is a QA/RA Specialist at StarFish Medical. Based in our Toronto office, Taimoor works on a variety of medical device projects. He follows his own advice on ROHS and REACH management and qualification regularly. This is his first blog for StarFish Medical.