If there’s one thing we can be sure of, it’s that the regulatory landscape is always evolving. In 2017, the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation was updated to include several new substances, while the Environmental Protection Agency began implementing amendments to the U.S. Toxic Substances Control Act.
The year to come also promises a number of regulatory changes. In-scope companies will have to meet new requirements across several product compliance regulations, including both REACH and the Restriction of Hazardous Substances (RoHS) Directive. The following list highlights the developments our regulatory experts believe will be most significant in compliance over the coming year.
Proposition 65 Labeling Requirements
On August 30, 2016, Article 6 of the California Safe Drinking Water and Toxic Enforcement Act, better known as Proposition 65, was amended to clarify warning label requirements. When these new requirements come into effect on August 30, 2018, labels and signage must include:
- The name of at least one Proposition 65-listed substance
- A pictogram to increase visibility
- Either a short or long form warning, though long form warnings are strongly recommended
In addition, manufacturers are encouraged to tailor warnings for their specific industries. For example, a vehicle manufacturer might include a reference to carbon monoxide, phthalates and lead contained in exhaust.
Once a substance is added to the Proposition 65 list, companies have 12 months to provide an adequate warning for in-scope products. Failure to comply puts companies at risk of fines of up to $2,500 per day, per exposure incident, as well as additional legal action related to competition laws in the state.
Know your requirements for Proposition 65. Download Your Guide to Understanding Proposition 65 Labeling Requirements.
RoHS Phthalate Elimination
Under the EU RoHS Directive, additional restrictions on four phthalates are due to come into force on July 22, 2019. The substances in question are:
- Bis(2-ethylhexyl) phthalate (DEHP)
- Diisobutyl phthalate (DIBP)
- Dibutyl phthalate (DBP)
- Benzyl butyl phthalate (BBP)
Restrictions on these phthalates apply to all electrical and electronic equipment (EEE) except for medical devices and monitoring and control instruments (Categories 8 and 9). Restrictions on these devices come into effect on July 22, 2021 instead.
Companies that currently manufacture or sell products containing these substances in the EU must act now to meet new requirements under the Directive. Between finding alternate substances, testing products for mass production and sale, and applying for new certification, the process of complying with the Directive could take months to complete.
New UAE RoHS Restrictions Come Into Effect
As of January 1, 2018, new restrictions are in effect for substances being manufactured or sold in the United Arab Emirates (UAE). These restrictions apply to the following substances in EEE (except medical devices, monitoring and control equipment, and Category 11 products):
- Lead (Pb)
- Mercury (Hg)
- Cadmium (Cd)
- Hexavalent chromium (Cr6+)
- Polybrominated biphenyls (PBB)
- Polybrominated diphenyl ether (PBDE)
Companies that have not addressed their obligations under the regulation must do so in 2018. Additionally, now that these restrictions are in force, companies should start thinking about the next UAE RoHS deadline.
On January 1, 2020, restrictions will come into effect for medical devices, in vitro diagnostic medical devices, monitoring and control instruments, industrial monitoring and control instruments, and Category 11 devices that contain the above substances. Restrictions on DEHP, BBP, DBP and DIBP in EEE (including cables, spare parts for repair, and the reuse, updating of functionalities or upgrading of capacity of EEE) will also apply.
REACH Candidate List Updates
On January 15, 2018, the European Chemical Agency (ECHA) added seven new substances to the REACH Candidate List. These include:
- Cadmium nitrate
- Cadmium hydroxide
- Cadmium carbonate
- 1,6,7,8,9,14,15,16,17,17,18,18- Dodecachloropentacyclo[220.127.116.11,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”TM) (covering any of its individual anti- and syn-isomers, or any combination thereof)
- Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) (with ≥0.1% w/w 4-heptylphenol, branched and linear)
Additionally, the entry for Bisphenol A was updated to include its environmental endocrine-disrupting properties.
In-scope companies will need to start collecting information on these substances, as well as the substances added to the Candidate List in 2017. Historically, new substances have been added to the Candidate List in June and December, so companies can expect to see further additions to the list later this year.
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REACH Registration Deadline
May 31, 2018 marks the final deadline for REACH registration. After this date, any substance imported into the EU at more than one ton per year must be registered with the ECHA. Producers of chemical substances that have not registered with the ECHA must cease importation until they have received approval. As such, companies must act quickly in advance of the deadline to avoid losing market access.
Publication of IPC-1754
The Materials and Substances Declaration for the Aerospace and Defense, and Other Industries standard, better known as IPC-1754, is expected to be published in early 2018. Sponsored by the International Aerospace Environmental Group (IAEG), it gives companies access to a standard XML template that can be used to respond to multiple regulatory requirements, including REACH and RoHS. The standard recommends the use of an industry-defined declarable substance list so that suppliers can have a common list of substances across their customers rather than different lists for each.
The Road Ahead
Throughout 2018, significant updates will come into force for several product compliance regulations. As new substances are added to restriction lists and the compliance landscape continues to expand, companies may struggle to keep up with their compliance obligations. It isn’t enough to focus on this year’s requirements alone. Companies must look ahead to 2019 and 2020, and begin the process of meeting those requirements as well.
If your company is in scope, you’ll need to adapt and respond quickly to these increasing demands. Having the tools and knowledge to anticipate future regulatory changes will keep you from falling behind in your compliance activities, allow you to maintain market access and help you avoid penalties associated with non-compliance.
The Assent Compliance Platform consolidates all your compliance needs into one centralized solution, helping you easily manage and meet your various product compliance obligations. You’ll also have access to a team of regulatory experts that will ensure you have the information you need to prepare for future changes. Get in touch with us at firstname.lastname@example.org to find out how partnering with us can transform your company’s compliance program.