Let’s face it: industry regulations can be an annoyance. They make things more complicated, add time and expense, and are always changing. But they do also serve an important purpose: These laws are aimed at reducing the impact to health, minimizing security threats, and being respectful to the environment.
The U.S. alone has almost 200 industry regulations issued per annum—from the FDA, OSHA, DoE, and others. The most common regulations cover areas such as:
- Energy efficiency
- Product takeback and recycling
- Chemical emissions
- Use of refrigerant
- Use and treatment of raw materials
- Use of ozone depleting substances
- Use of conflict minerals
- Health and safety practices
However, just breaking it down into general categories is deceptively simple because the requirements created by each law will depend on the product and the markets in which the electronics company competes. For example, environmental regulations may change based on local laws regarding emissions, water discharge, and waste.
Who is Responsible for Compliance?
Normally it is the responsibility of the electronic manufacturer to observe these rules and stay compliant at all times. But in order to ensure success, you should take a proactive approach to staying on top of regulations as well. This includes evaluating your outside resources and consultants as well as understanding the regulations of foreign countries if you plan to sell your product internationally.
Common Regulations to Monitor
To make sure this doesn’t happen, it helps to be ready beforehand. Here is a list of the six biggest regulations that could impact your supply chain:
1. Restriction of Hazardous Substances (RoHS)
The RoHS rule is governed by the European Union, and is not U.S. law, although the U.S. has similar regulations in some states. This affects most electronic products, including lamps, power tools, computers, appliances, sports equipment and more as it prohibits or restricts the use of these common substances:
a. Lead
b. Mercury
c. Cadmium
d. Hexavalent chromium
e. Polybrominated biphenyls
f. Polybrominated diphenyl ether
2. Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
The REACH law is another EU rule that regulates chemicals substances—not only those used in industrial processes but also in cleaning products, paints, articles of clothing, furniture, and electrical appliances. If you make chemicals, either to use yourself or to supply to other people, then you will probably have some important responsibilities under REACH.
3. Conflict minerals as defined under the Dodd-Frank Act
When the Dodd-Frank Act was signed it included a provision that public companies must be able to prove their sourced minerals—most commonly tantalum, tin, gold, and tungsten—must be sourced and transported from a location cleared by the U.S. as a place that does not finance conflict in the Democratic Republic of the Congo or an adjoining country. Often the sources are disguised through smuggling or some other tactic. A reputable company takes care to ensure that its products are sourced appropriately.
4. Waste from Electrical and Electronic Equipment (WEE)
WEE requires that electronic equipment—such as computers or batteries—be recyclable and that the manufacturer is able to collect the items to recycle the products. Essentially, a business that sells computers or items with a battery must also collect the old computers and batteries it receives and return them to their respective manufacturers.
5. Traceability of pharmaceuticals and medical equipment
The Food and Drug Administration (FDA) monitors both the The Drug Supply Chain Security Act, along with the Unique Device Identification (UDI) rules. These state that companies must always have an adequate amount of information about the raw materials their products are made from, including all data about the suppliers and the carriers that shipped the raw materials to the factory.
6. Title 21 CFR Part 11
Another regulation overseen by the FDA, this determines what is considered an appropriate record for usage in a compliance program. This relates to traceability, as well as food delivery records and is a complex rule, so companies often must take multiple steps and have many different procedures in place to ensure they meet compliance with the regulations.
A Partner who Knows Industry Regulations
It’s important to ensure your electronics assembly partner and procurement team are keeping track of these and other regulations. ACDi has a team that stays on top of electronics supply chain industry regulations, and brings our partners up to speed with any changes or issues that may affect them. With every project, we review a bill of materials and provide guidance if there is anything that may be out of compliance. We understand that a reactive approach can cost in penalties and loss of market opportunity if a product is banned, so we proactively keep clients informed, with as little disruption to schedules as possible.