It’s been a busy summer. Here are few of the new requirements sure to make your life more exciting.
ECHA – Six new proposed Substances of Very High Concern
On September 6, ECHA opened a 45 day public consultation concerning the addition of six chemical substances to the Candidate List of Substances of Very High Concern.
Potentially the most impactful substance included is 4,4’-isopropylidenediphenol, or bisphenol A (BPA), which is listed as “Toxic for reproduction (Article 57 c)”. While BPA itself will rarely (intentionally) end up as an existing constituent in a finished electronic device, its use is extensive as an intermediate or ingredient for producing such ubiquitous materials as epoxy resins and polycarbonates. Therefore the biggest potential impact would be on manufacturing plants in the European Union if it were added to Annex XIV. EU-based manufacturers would then have to either replace it, apply for authorization to continue using it, or move production out of the EU.
The others are primary monomers and intermediates, and are constituents of polymers or lubricants. As with all SVHCs, review your use and your supply chain’s use of these substances to understand how this could potentially impact you.
The consultation closes on October 21. Normally ECHA publishes the resulting revised Candidate List in mid-December.
US TSCA Reform
After more than a decade of attempts, the U.S. Congress – despite its stunning inability to do its job – passed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act”, and President Obama signed it into law on June 22. The US Environmental Protection Agency wasted no time in producing its “First Year Implementation Plan” on June 29. The plan includes developing procedures for prioritization as well as fee structures. Manufacturers and users of chemical substances and mixtures should pay close attention to these developments.
While the impact to articles remains to be seen, the law explicitly allows substance or mixture prohibitions or restrictions in articles “only to the extent necessary to address the identified risks from exposure to the chemical substance or mixture from the article or category of articles so that the substance or mixture does not present an unreasonable risk of injury to health or the environment identified in the risk evaluation conducted in accordance with subsection (b)(4)(A).”
Keep track of the EPA as it moves forward on assessing and implementing its responsibilities fo what is now being called LCSA (for “Lautenberg Chemical Safety Act”), and sign up for their mailing list, here as well.
California Proposition 65: New Warning Requirements
Revisions to Article 6, “Clear and Reasonable Warnings”, were issued on August 30, 2016, to take effect in two years, on August 30, 2018. Anyone who lives in California sees the warnings seemingly everywhere and we’ve all pretty much become numb to it. In an attempt to inject some new life into the 30 year old law, what was a warning rendered meaningless by its ubiquity and vagueness may now require significant effort on the part of manufacturers in order to meet the new requirements.
One of the key features of the new warning is the inclusion of the name of the listed substance responsible for the warning. In the case where both carcinogenicity and reproductive toxicity are of concern and are the result of two separate substances, both will have to be listed. § 25603, “Consumer Product Exposure Warnings – Content” describes the actual warning, which consists of three parts:
1. A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”.
2. The word “WARNING” in all capital letters and bold print, and:
3. A variation, depending on the situation, on this text for exposures to listed carcinogens: “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
This warning may be on the product, its packaging, or otherwise clearly displayed at the point of display of the product (e.g., shelf in a retail outlet or on the webpage for the product sold by an internet seller).
While some manufacturers have side-stepped responsibility by simply adding the label to the product or its packaging without doing the work to determine whether or not it is actually necessary, this is set as a less desirable option now. An alternative warning is provided that is perhaps a bit scarier to the average consumer, but does not require the manufacturer to either verify the presence of a specific chemical substance or disclose it: the manufacturer can simply put the symbol and “WARNING” note as indicated above, along with a short phrase: “Cancer - www.P65Warnings.ca.gov” on the actual product. “The entire warning must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall the warning appear in a type size smaller than 6-point type.”
The new section does clarify that “consumer product means any article, or component part thereof, including food, that is produced, distributed, or sold for the personal use, consumption or enjoyment of a consumer.” Manufacturers of industrial/business products are not quite off the hook, since “occupational exposure” could occur due to coming into contact with a product at his/her place of business.
There are many more important details regarding the revised warnings that manufacturers must understand than I can cover here. Visit OEHHA’s Prop65 website to learn more.
Finally, Singapore introduced its version of the EU’s RoHS requirements: “the Environmental Protection and Management Act (Amendment of Second Schedule) Order 2016”. Coming into force on June 1, 2017, the law now restricts the original six RoHS substance and their compounds in homogeneous materials in a relatively narrow scope of products. “’Controlled EEE’ means any air-conditioner, flat panel display television, mobile phone, phablet, portable computer, refrigerator or washing machine, that is designed for household use (whether or not the controlled EEE is also designed for any non-household use).”
The text includes exemptions indirectly copied from the EU RoHS Directive, 2011/65/EU, and organized by substance (the actual organization seems like an improvement over the EU’s approach), however like so many other similar regulations around the world, it’s unclear whether and how they will maintain it.
Read it for yourself here (incorporated into the existing Environmental Protection and Management Act) and take action as needed.
Visit DCA at www.DesignChainAssociates.com or email me with any questions or comments on this post.