Over the past fifteen years, the European Union has implemented sweeping production standard mandates in response to growing concerns over consumer health, safe factory conditions along the supply chain, and environmental protection.
EU’s Pathbreaking Standards: RoHS Directive and REACH Regulations
We can gain a sense of the EU’s overall ambition, attention to detail and commitment to transparency by looking at two of its most substantial pieces of product legislation:
- RoHS -- Restriction of Hazardous Substances -- pronounced like “rose”; and
- REACH -- Registration, Evaluation, Authorization and Restriction of Chemicals
RoHS (Restriction of Hazardous Substances)
The RoHS is a directive regulating the manufacture, import and distribution of Electronics and Electrical Equipment (EEE) within the EU, which bans from use 6 different hazardous materials (to date).
The first RoHS iteration (RoHS 1) hit the market on July 1, 2006 with a list of 6 chemicals (Lead, Mercury, Cadmium, Hexavalent Chromium, Polybrominated Biphenyls, and Polybrominated Diphenyl Ether). The content of these chemicals in any “homogeneous” material -- meaning any single substance such as plastic -- cannot exceed 0.1% or 1000 parts per million, with the exception of Cadmium, where the threshold is even lower, at0.01% or 100 ppm.
For RoHS 1 compliance, a company was required to maintain and keep records of compliance, using this iconic green check on all EEE products cleared for market.
RoHS 2, which took effect on January 2, 2013, expanded the scope of the directive to more products, like electric cables and spare parts, and stepped up documentation requirements for thoroughness and frequency of updates.
Additionally, RoHS 2 requires compliance recordkeeping from everyone in the supply chain and not just from the company selling the finished product.
For compliance labelling, the Green Check was replaced with the more uniform CE "Conformité Européene" marking.
Since RoHS 1, four additional chemicals -- specifically, 4 types of phthalates -- have been added to the list. The change will take full effect on July 22, 2019. These new additions to the list indicate a stronger focus on safer children’s toys, which are often heavy with phthalates for that softer feel.
REACH Regulations
REACH Compliance is broader in scope (the broadest, really) and takes a different approach to regulation and documentation.
REACH applies to basically every product manufactured, imported or sold within the EU. In a way, REACH is a way for the European Chemicals Agency (ECHA) to collect information about virtually every chemical substance used for day-to-day and industrial products.
REACH deals more in the regulation of chemical substances, particularly those known as Substances of Very High Concern (SVHC). Substances considered carcinogenic, mutagenic, toxic for reproduction, or bioaccumulative fall under SVHC criteria.
EU manufacturers and importers are required to register all substances produced above a set yearly volume to:
- Identify the risks associated with the substances they produce.
- Demonstrate to the ECHA the ability to manage those risks.
- Establish safe use guidelines for their product so that the use of the substance does not pose a health threat.
The yearly volume threshold will shrink to 1 ton per year by May 31, 2018.
Additionally, there are now nearly 200 SVHCs requiring authorization for use by the ECHA, and the list will continue to grow.
A New Reality in Production Standards
Today’s changing market is following a more conscientious path to material production. What goes into each product is just as important as how it turns out. People are concerned about their family’s health, safe labor practices, and the environment. The European Union has established itself as a leader in safe production legislation, and it is reverberating throughout the world.
QIMA will help you stay connected with this new market with quality assurance and top-tier lab testing.
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