REACH, BPA, DEHP, WEEE??? This is not your mother’s alphabet soup but acronyms for new environmental compliance directives, regulations, and initiatives…
As the world shrinks and companies continue to span many continents, we are seeing an increase in global environmental and safety regulations. Many of these are being initiated in Europe and are spreading throughout Asia and within our own country. Directives like REACH, WEEE, RoHS, and GHS are driving many companies crazy as they try to understand how the directives affect them. Initiatives to identify and eliminate DEHP and BPA use in plastics and adhesives are also plaguing many manufacturers. Very few international companies are immune from these new directives and initiatives.
It’s important to understand each one and how it affects your specific business before investing resources. In today’s economy companies must invest their resources wisely in order to stay competitive. It is important to understand the impact of these new regulations and initiatives both financially and from the safety and compliance perspective before moving forward.
What are they?
REACH, a new European Community Regulation on chemicals and their safe use, entered into law on June 1st 2007. The legislation addresses the Registration, Evaluation, Authorization and restriction of Chemical substances. The main objective of REACH is to improve the protection of human health and the environment from the risks that can be posed by chemicals used in an industry.
REACH makes industries responsible for assessing and managing the risks posed by these chemicals and provides the appropriate safety information to their users. The criterion is based on volume (equal or greater than 1 metric tonne) imported into the European Union (EU) or if it is a Substance of Very High Concern (SVHC). Registration of the substances occurs in phases based on the previously mentioned criteria, with the last occurring in 2018. Learn more.
WEEE or Waste Electrical and Electronic Equipment is another directive (Directives 2002/95/EC & 2002/96/EC) from the EU which restricts the use of hazardous substances (see RoHS) in electrical and electronic equipment while promoting the collection and recycling thereof. The recycling program is aimed at re-using electronic waste and encourages consumers to return outdated, broken electronic equipment to the manufacturers at no cost to the consumers. This eliminates the used electrical and electronic equipment from ever reaching a landfill where it would contaminate the environment with harmful substances that could potentially leech out. WEEE goes hand-in-hand with RoHS. Learn more.
RoHS or the Restriction of Hazardous Substances (directive 2002/95/EC) works closely with WEEE and is designed to shift manufacturers away from restricted chemicals to safer alternatives. The EU identified the following substances under RoHS as hazardous with a significant impact to the environment. They are:
- Cadmium (Cd)
- Lead (Pb)
- Hexavalent Chromium (CrVI)
- Mercury (Hg)
- Polybrominated biphenyls (PBB)
- Polybrominated diphenyl ether (PBDE )
Additionally, the EU restricted three other flame retardants under 2003/11/EC for their negative impact on human health and the environment.
- Pentabromodiphenyl ether (PentaBDE)
- Octabromodiphenyl ether (OctaBDE)
- Decabromodiphenyl ether (DecaBDE)
Please click here for more information.
GHS or Globally Harmonized System of classifying and labeling of chemicals is a regulation that was created in collaboration with the members of the United Nations (UN). Essentially, this regulation looks at unifying and standardizing all classification and labeling of chemicals so they are globally harmonized. This means whether you are in Russia, France, Mexico, or the United States the safety information would be communicated in an identical manner through pictograms, hazard warnings, signal words, etc. Read more from the OSHA website. Each specific country’s adoption of this new standard will vary. Click here to learn more about your specific country’s adoption schedule for GHS.
DEHP and other phthalates
Di(2-ethylhexyl)phthalate (DEHP) is a plasticizer added to polyvinyl chloride (PVC) to make the normally rigid plastic more flexible. Many companies, especially those in the medical device industry, are requiring suppliers to inform them of DEHP or other phthalate use. The FDA issued a health warning1 advising the public that DEHP could leech out of PVC and pose a health risk in certain high risk groups. Specifically, there are concerns pertaining to the effects on the development of the male reproductive system. More information is available from the FDA website.
Bisphenol A2 is a key ingredient in the manufacturing of polycarbonate and a constituent within many epoxies. “In recent years, a hypothesis has been advanced claiming that exposure to extremely low doses of certain substances could cause adverse health effects in humans, including disruption of normal hormonal functions.”2 There have been many conflicting studies completed showing that in some cases there is concern to human health but in other studies demonstrating no harmful effects. Based on some initial tests through the National Toxicology Program (NTP) it appears as though there is “some concern” especially in small children and infants. To alleviate some of the discrepancies in testing, NTP is requesting additional information from the scientific community pertaining to the health effects of BPA.3 It may be years before we really know whether there is truly a concern with BPA. It will probably be too late for industry however, who regardless of the outcomes, will have made the switch to BPA alternatives because of these initial concerns. More information on BPA can be found here.
Is there any good from these regulations and initiatives?
While many of these regulations and initiatives may be seen as cumbersome and confusing, some of them really are. They make sense when you look at the overall picture and what is trying to be accomplished. Many of the regulations are needed to reduce the impact and bioaccumulation of harmful chemicals in the environment, while minimizing or eliminating any risk to the safety and health of the greater population.
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1 Retrieved from the FDA website http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062182.htm
2 Retrieved from the website http://www.bisphenol-a.org/
3 Retrieved from the website