California Proposition 65

February 6, 2024 | Written by GreenSoft Technology, Inc.

One Chemical Added to California Proposition 65 Substance List

proposition-65Bisphenol S (BPS) added to the California Prop 65 regulated substances list

In December, California’s Office of Environmental Health Hazard Assessment (OEHHA) added one new substance to the list of chemicals regulated under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

Effective December 29, 2023, bisphenol S (BPS) has been added to the list of chemicals known to the State of California to cause reproductive harm. This listing was done via the “State’s Qualified Experts” mechanism, based on the Developmental and Reproductive Toxicant Identification Committee’s (DARTIC) determination that this chemical was clearly shown to cause female reproductive toxicity.

The warning requirement for significant exposures to this chemical will take effect on December 29, 2024.

Bisphenol S (BPS) is a key component in curing fast-drying epoxy resins which are found in printed circuit boards (PCBs), encapsulation materials for protecting delicate electronic components, and adhesives. It is a substitute for bisphenol A (BPA), which has also been linked to health concerns.

The full California Proposition 65 list of regulated substances can be found here. The announcement of the new substance addition can be found here.

GreenSoft Technology provides help with California Proposition 65

Complying with Prop 65 warning label requirements requires businesses to have detailed knowledge of the chemicals that their products or business locations contain and expose to the California public.

Affected companies are required to inform Californians about exposure to substances on the Prop 65 list of chemicals before the potential exposure takes place. Penalties for being found in violation of CA Prop 65 can be as high as $2,500 per violation, per day.

In order to know which chemicals are exposed to the public, a business must collect substance data on the products that it sells to the public in California or the products that it uses within its California business locations.

GreenSoft Technology can help with this process. As part of our Prop 65 Compliance Data Services, we will collect substance data from your suppliers on your behalf, and check it against the list of chemicals regulated under CA Prop 65.

Contact us to learn more.

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EU REACH

January 24, 2024 | Written by GreenSoft Technology, Inc.

Five Entries Added to EU REACH SVHC List

eu-reach-svhc

EU REACH SVHC List now contains 240 Entries

On January 23, the European Chemicals Agency (ECHA) announced the addition of 5 substances to the EU REACH Substances of Very High Concern (SVHC) Candidate List.

The 5 substances, as well as their reasons for inclusion and common uses, are listed in the table below. ECHA also updated the existing entry for dibutyl phthalate to include its endocrine disrupting properties (Article 57(f) - environment).

The EU REACH SVHC Candidate List now has 240 entries. However, some entries are groups of chemicals, so the overall number of impacted chemicals is higher.

The inclusion of substances in the EU REACH SVHC List brings immediate obligations for affected companies using the substances in their products above the stated threshold, including customer notification requirements and notifying ECHA through submissions to the SCIP Database. GreenSoft Technology can help with this process as part of our Data Services.

Substance Name EC Number CAS Number Reason for Inclusion Examples of use(s) in Electronics
2,4,6-tri-tert-butylphenol 211-989-5 732-26-3           Toxic for reproduction (Article 57c) Persistent, bioaccumulative and toxic (PBT) (Article 57d) Used as an antioxidant and stabilizer to prevent degradation of materials due to oxidative processes
2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol 221-573-5 3147-75-9 Very persistent and very bioaccumulative (vPvB) Used as a UV-absorber and light stabilizer to mitigate the adverse effects of ultraviolet radiation on materials and enhance their durability
2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one  438-340-0 119344-86-4 Toxic for reproduction (Article 57c) Used as a photoinitiator, facilitating the initiation of photochemical processes during the production of printed circuit boards and other light-curable materials
Bumetrizole 223-445-4 3896-11-5 vPvB  (Article 57e)   Used as a corrosion inhibitor to protect metal surfaces and components from corrosion and enhance the longevity of electronic devices
Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol  700-960-7 - vPvB  (Article 57e) Used as epoxy resin modifiers, enhancing the mechanical and thermal properties of epoxy-based materials used in electronic components and circuitry

ECHA’s announcement of the additions can be found here. The full SVHC-240 list can be found here. The last prior addition to the SVHC list was SVHC-235 in June 2023.

 

GreenSoft can help with EU REACH compliance

The EU REACH SVHC List is typically updated twice per year, resulting in affected companies needing to re-evaluate their product compliance and possibly re-collect substance data from their suppliers.

GreenSoft Technology helps manage this process for companies, including coverage for the SCIP Database, by performing data collection, data validation, substance calculations and report generation as part of our EU REACH data services.

Learn more about how our Data Services help your company with EU REACH compliance by contacting us.

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PFAS

January 22, 2024 | Written by GreenSoft Technology, Inc.

Introducing GreenSoft’s New PFAS Resource Center

Learn about PFAS Regulations and PFAS Compliance Requirements

GreenSoft Technology, Inc. has launched a new resource center to learn about PFAS regulations around the globe.

Visit our new PFAS webpage to learn about PFAS compliance requirements for existing and upcoming regulations, including:

  • U.S. state PFAS regulations in Maine and Minnesota
  • U.S. Toxic Substances Control Act (TSCA) Section 8(a)(7)
  • California Proposition 65
  • EU REACH Substances of Very High Concern (SVHC)
  • EU Persistent Organic Pollutants (POPs)

You’ll be able to access our PFAS Frequently Asked Questions section, read PFAS-related blog posts, and view video clips and full-length webinars on PFAS regulations and updates.

Due to their persistence and adverse health effects, PFAS “forever chemicals” have gained traction in the media, and regulatory bodies across the globe are enacting new regulations to ban or regulate the use of PFAS chemicals.

These regulations have widespread implications, affecting manufacturers across various sectors, including electronics production. Explore our PFAS resource center today to gain essential insights and ensure your company's compliance with both existing and upcoming PFAS regulations.

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Market Access

January 11, 2024 | Written by GreenSoft Technology, Inc.

ECHA Enforcement Project Removes Hundreds of Products from Market due to REACH Compliance Violations

18% of consumer products inspected by ECHA Forum contained Hazardous Chemicals, violating REACH compliance

An EU-wide enforcement project conducted by the European Chemicals Agency (ECHA) Forum has found excessive levels of hazardous chemicals, such as lead and phthalates, in a substantial number of consumer products. The findings, released on December 13, 2023, indicate that 18% of inspected products violated EU chemical laws.

The ECHA enforcement project, carried out in 26 countries throughout 2022, focused on assessing EU REACH compliance, Persistent Organic Pollutants (POPs) compliance, EU RoHS compliance, and restrictions derived from the Toys Directive. National enforcement authorities inspected over 2,400 products and found more than 400 of them in violation of EU laws.


The most common products found in violation include:

Electronic Devices:

  • Categories such as electrical toys, chargers, cables, and headphones showed the highest non-compliance rate at 52%.
  • Violations were mainly attributed to lead in solders, phthalates in soft plastic components, and cadmium in circuit boards.

Sports Equipment like yoga mats, bicycle gloves, balls, and rubber handles:

  • 18% of these products were found to be non-compliant mainly due to the presence of Short-Chain Chlorinated Paraffins (SCCPs) and phthalates in soft plastic, along with Polycyclic Aromatic Hydrocarbons (PAHs) in rubber.

Non-electric Toys:

  • 16% of toys such as bathing/aquatic toys, dolls, costumes, play mats, and fidget toys, outdoor toys, slime and childcare articles were found to be non-compliant.
  • Phthalates found in soft plastic parts were the primary violation, with additional violations for the presence of other restricted substances like PAHs, nickel, boron, or nitrosamines.

Fashion Products:

  • 15% of fashion products such as bags, jewelry, belts, shoes, and clothes were found to be non-compliant due to the presence of phthalates, lead, and cadmium.

The non-compliance rate was higher among products originating outside the European Economic Area (EEA) and products of unknown origin.

For manufacturers found in violation, the enforcement measures taken by inspectors were swift and decisive, often resulting in the removal of non-compliant products from the market. This serves as a stark reminder of the significant financial and reputational consequences for non-compliant manufacturers.


GreenSoft’s data services can help prevent loss of market access for regulation violations

EU REACH compliance, EU RoHS compliance and compliance with Persistent Organic Pollutants (EU POP) is mandatory for affected companies that manufacture or distribute products in the European market. As demonstrated by this recent ECHA enforcement project, failure to comply with these regulations can result in loss of market access, supply chain disruptions, and other serious consequences for manufacturers and distributors.

GreenSoft Technology provides personalized Data Services and GreenData Manager software to the electronics manufacturing industry. We’ll help your company ensure supply chain compliance so that you retain access to the European market.

Learn more about our Environmental Compliance Data Services or contact us today to get started.

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Market Access

December 13, 2023 | Written by GreenSoft Technology, Inc.

Over 100 Products Recalled from European Market Due to EU RoHS Violations

eu-rohs-violation-recallsNumerous products forced to be removed from European market due to EU RoHS and EU POP violations

In the fourth quarter of 2023, importers of over 100 products were ordered to recall their products from the European market for failure to comply with the EU RoHS Directive. Several of the products were also found to be non-compliant with the EU Persistent Organic Pollutants (POP) Regulation.

The EU RoHS Directive imposes restrictions on the presence of specific substances and prohibits certain chemicals in items sold within the European Union. Products discovered to be non-compliant with EU RoHS must be removed from the European market due to environmental concerns.

Products recalled in the fourth quarter of 2023 include wireless earbuds, electronic cables, flashlights, gaming controllers, remote controls, and Bluetooth speakers.

The recalls were announced via EU Safety Gate alerts. The following are 3 examples out of over 100 total enforcement actions for this quarter.


Wireless Earbuds

wireless-earbudsDescription:

The solders of the product have an excessive concentration of lead (measured value up to 2.02% by weight). Lead poses a risk to the environment.

Regulation Violation(s):

EU RoHS 2 Directive

Alert Number/Link:

A12/02656/23


Optical Mouse

optical-mouseDescription:

The solders in the product have an excessive concentration of lead (measured value: up to 52 % by weight). The plastic material of the cable has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and short chain chlorinated paraffins (SCCPs) (measured values: up to 1.45 %, 0.28 % and 2.6 % by weight, respectively). Plastics in the product have an excessive concentration of polybrominated diphenyl ethers (PBDE) (measured value: 0.9 % by weight). Lead poses a risk to the environment. DEHP and DBP pose a risk to human health and the environment. PBDE might cause neurodevelopmental behavioural defects and is very persistent and bio-accumulative, posing a risk for the environment and human health. SCCPs persist in the environment, are toxic to aquatic organisms at low concentrations and bio-accumulate in wildlife and humans, posing a risk to human health and the environment. Prolonged exposure to them through the skin may cause cancer.

Regulation Violation(s):

EU RoHS 2 Directive

Persistent Organic Pollutants (POP) Regulation

Alert Number/Link:

A12/02743/23


Power Supply

power-supplyDescription:

The solders in the product have an excessive concentration of lead (measured value up to 9.22% by weight). Lead poses a risk to the environment.

Regulation Violation(s):

EU RoHS 2 Directive

Alert Number/Link:

A12/02587/23


GreenSoft’s data services can help prevent loss of market access for regulation violations

Compliance with EU RoHS and EU POP is mandatory for affected companies that manufacture or distribute products in the European market. As demonstrated by the enforcement actions above, failure to comply with this regulation can result in loss of market access and other serious consequences for manufacturers and distributors.

GreenSoft Technology provides Data Services to help your company comply with EU RoHS and EU POP, so that you can ensure you retain market access to the European market.

Learn more about our Data Services or contact us today to get started.

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EU RoHS Exemptions Timeline Update

EU RoHS Exemptions Updates: European Commission announces target adoption dates expected in third quarter 2024 for critical EU RoHS exemptions for electronics manufacturers

California Proposition 65

December 12, 2023 | Written by GreenSoft Technology, Inc.

Three Chemicals Added to California Proposition 65 Substance List in November

proposition-65Coal-Tar Pitch, Fluoro-Edenite Fibrous Amphibole, and Silicon Carbide Whiskers added to the Proposition 65 regulated substances list

Last month, California’s Office of Environmental Health Hazard Assessment (OEHHA) added three new substances to the list of chemicals regulated under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

Effective November 17, 2023, the following three substances have been added to the list of chemicals known to the State of California to cause cancer:

  • Coal-Tar Pitch
  • Fluoro-Edenite Fibrous Amphibole
  • Silicon Carbide Whiskers

Coal-tar pitch is used as a binder in the production of carbon and graphite materials, including electrodes for electric arc furnaces and anodes in aluminum production. Coal-tar pitch is often employed in the manufacturing of high-performance carbon composites used in aerospace and electronic components due to its ability to provide structural integrity and thermal stability.

Silicon carbide whiskers are frequently used as reinforcement in composites for semiconductor device fabrication, enhancing materials in electronic packaging, printed circuit boards, and high-temperature electronics.

Fluoro-edenite fibrous amphibole is not commonly used in electronic applications.

California law requires that certain substances identified by the International Agency for Research on Cancer (IARC) be listed as known to cause cancer under California Proposition 65. The IARC recently concluded that coal-tar pitch and fluoro-edenite fibrous amphibole carcinogenic to humans, and that silicon carbide whiskers are probably carcinogenic to humans. Additionally, IARC concluded that there is sufficient evidence of carcinogenicity in humans and animals for coal-tar pitch and fluoro-edenite fibrous amphibole, and that there is sufficient evidence of carcinogenicity in animals for silicon carbide whiskers.

The full California Proposition 65 list of regulated substances can be found here. The announcement of the three new substance additions can be found here.

GreenSoft Technology provides help with Proposition 65

The inclusion of these three substances in the California Proposition 65 regulated substances list brings about immediate obligations for affected companies. In order to comply with the obligations under California Proposition 65, businesses must have detailed knowledge of the chemicals that their products or business locations contain and expose to the California public.

Affected companies are required to inform Californians about exposure to substances on the Proposition 65 chemicals list before the potential exposure takes place. Penalties for being found in violation of CA Prop 65 can be as high as $2,500 per violation, per day.

In order to know which chemicals are exposed to the public, a business must collect substance data on the products that it sells to the public in California or the products that it uses within its California business locations. GreenSoft Technology can help with this process.

As part of our California Proposition 65 Data Services, we will collect substance data from your suppliers on your behalf, and check it against the list of chemicals regulated under CA Prop 65. Contact us to learn more.

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UKCA Mark

December 5, 2023 | Written by GreenSoft Technology, Inc.

Clarification on the usage of the CE Mark in the United Kingdom

CE-Mark-in-UK-Main-ImageDespite announcement of indefinite recognition of CE Mark, many manufacturers face UKCA Marking requirements for products sold in the United Kingdom

As previously reported, on August 1 the UK Department for Business and Trade (DBT) announced it would indefinitely recognize use of the CE Mark for products sold in the United Kingdom. Previously, affected companies had until December 31, 2024 to transition to usage of the UK Conformity Assessed (UKCA) mark.

However, this decision by the UK DBT only affects products that fall under one of the 18 regulations in the UK DBT regulatory scope, listed here.

Under the current requirements, products falling in scope of other UKCA regulations which are not administered by DBT, such as the UK RoHS Regulation, would still need to apply the UKCA Mark in order to be sold in the UK market after December 31, 2024. This also applies to products which fall in scope of a referenced UK DBT regulation and one or more UKCA regulation(s) administered by other UK agencies. For example, a device which is in scope for both the UK EMC regulation and the UK RoHS regulation would require UKCA marking, because while the UK EMC directive is included in the indefinite CE Mark acceptance announcement, the UK RoHS regulation is not.

The UK Department for Environment Food and Rural Affairs (DEFRA), which administers the UK RoHS regulation, as well as other UK regulatory bodies, have not changed their existing rules requiring the UKCA Mark. Products that must comply with the UK RoHS regulation currently have an obligation to display the UKCA Mark by the December 31, 2024 deadline.

Industry insiders expect that DEFRA may make an announcement harmonizing the UK RoHS regulation’s marking requirements with the UK DBT announcement, and thereby also recognizing the CE Mark indefinitely going forward. However, no such announcement has been made yet, and no expected timeframe for such an announcement has been provided. Until such an announcement is made, companies affected by the UK RoHS regulation must continue to adhere to the existing UKCA Marking rules and the upcoming December 31, 2024 deadline for compliance.

GreenSoft Technology helps with UK regulations and data collection

With the scopes and deadlines of rules such as the UK RoHS regulation and the UKCA Mark requirements continually changing, it can be difficult for manufacturers to keep up. As part of our Data Services, GreenSoft Technology monitors regulations and keeps you up-to-date on changes that affect your company.

Our data team will collect and validate data from your supply chain which can be used to ensure your compliance with UK RoHS and other regulations, and help with aspects of the CE marking and UKCA marking requirements. Contact us to learn more.

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California Proposition 65

November 27, 2023 | Written by GreenSoft Technology, Inc.

Proposal to Change California Proposition 65 Warning Labels Reintroduced

proposition-65Rulemaking process restarted to evaluate amendments to short-form warning labels under California Proposition 65

On October 27, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced its intention to amend the short-form warning label requirements under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

The proposal intends to make the Proposition 65 short-form warning labels more informative to consumers by requiring identification of a specific chemical exposure for which the warning is being given.

The proposal would also add new sections to the regulation in order to create tailored warning methods and content for exposures to listed chemicals from passenger or off-highway vehicle parts and recreational marine vessel parts. The regulations would ensure that California consumers buying these parts receive a warning about their exposure and information about reducing the risk of exposure to listed chemicals.

A similar proposal was first proposed by OEHHA in December 2021, but that rulemaking effort lapsed in May 2022 without resulting in an official amendment to the regulation. This latest proposal is a reintroduction of the initial proposal.

What does this mean for product producers?

Because Proposition 65 enforcement legislative actions can result in multimillion-dollar settlements, many companies choose to simply place the short form warning on their products to avoid the risk of any such actions. This short form warning includes a hazard symbol, the word “WARNING,” and a statement as follows: “[type of risk] -- www.P65Warnings.ca.gov.”  An obligation to disclose the actual substance at risk of exposure is not included in the current short form warning. This enables companies to avoid liability by applying the warning without performing any due diligence as to the product’s actual risk of exposure.

OEHHA is concerned that this leads to overuse of the warning. As a result, OEHHA seeks to end this practice with this proposed change. Under this proposed amendment, product producers will be required to disclose the specific substances at risk of exposure in the short form warning. This requirement seeks to compel product producers to perform due diligence to determine which hazardous substances are present in their products and which of those substances present a risk of unsafe exposure.

Example of a current short form warning label (without chemical names included):

CA65-old-label

Example of proposed short form warning (with chemical names included):

CA65-new-label

Affected companies would have two years from the effective date of the latest proposed amendments to comply with the new short-form warning label requirements.  A product manufactured before the two-year deadline can use the current warning regardless of when it is sold to the customer.

OEHHA has scheduled a public hearing regarding the proposal on December 13, 2023 in Sacramento, CA. Interested parties may also submit written comments online through December 20, 2023. Comments may be submitted electronically through the OEHHA website at https://www.oehha.ca.gov/comments.

OEHHA’s announcement of the proposal can be found here. The full regulatory text of the proposal can be found here.

GreenSoft Technology provides help with Proposition 65

GreenSoft Technology will continue to track updates from OEHHA, and will alert our readers via our blog when the new rulemaking proposal is published and when the final decision is made.

GreenSoft Technology provides companies with the substance data needed to comply with California Proposition 65. As part of our California Proposition 65 Data Services, we will collect substance data from your suppliers on your behalf, and check it against the list of chemicals regulated under CA Prop 65.

Contact us to learn more.

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Toxic Substances Control Act (TSCA)

November 22, 2023 | Written by GreenSoft Technology, Inc.

EPA Makes Changes to Rules Regarding PBT Chemicals Regulated Under TSCA

TSCAChanges to scope, exclusions, and deadlines regarding the use of PIP (3:1) and decaBDE

On November 16, the U.S. Environmental Protection Agency (EPA) released a pre-publication notice of proposed changes to the rules for Persistent, Bioaccumulative, and Toxic (PBT) chemicals regulated under the U.S. Toxic Substances Control Act (TSCA).

Among other changes, the proposed new rules affect the scope of the regulation, the various industry exclusions or exemptions, and the deadlines for compliance. Many producers of electronic equipment will be impacted by the changes included in the proposal.

The proposed changes to the TSCA regulation come after the EPA released final rules on January 6, 2021 to reduce exposures to five PBT chemicals. In 2021, the EPA announced that it was reviewing these rules in light of Executive Orders and other guidance provided by the Biden-Harris Administration. And in March 2022, the EPA extended the enforcement deadline for PIP (3:1) compliance to October 2024.

The proposed changes to the rules only apply to PIP (3:1) and DecaBDE prohibitions, and do not impact the other three PBT substances restricted under 40 CFR Part 751 Subpart E. All existing prohibitions on 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP), Hexachlorobutadiene (HCBD), and Pentachlorothiophenol (PCTP) will remain unchanged and in force.

The EPA‘s announcement of the proposed changes can be found here. The full text of the pre-publication of the regulation can be found here. GreenSoft Technology has created a red-lined version of the amended regulation text so that readers can see the changes between the old and new versions. Download our red-lined version of the regulation here.

Notable changes affecting electronic equipment

Some notable changes affecting the electronics industry are included in the proposed new rule. Changes affecting electronic equipment, which involve PIP 3:1 only, include, but are not limited to:

  • A permanent exclusion has been provided for the use of PIP (3:1) in products manufactured for use in circuit boards and wire harnesses. As such, many electronic components will no longer be in scope. However, this applies to PCB assemblies only. Enclosures, pumps, motors, fasteners, and other items which are not specifically intended to be used on a circuit board would still be in scope.

The specific definition of what constitutes “used in circuit boards” remains undefined. Interested parties are encouraged to submit their questions and concerns to the EPA during the comment period, as explained below, to request clarification.

  • The exclusion of the use of PIP (3:1) in lubricants and grease from the regulation has been narrowed. PIP (3:1) will now only be excluded from restrictions when used in lubricants and grease used for aerospace and turbines.

For all other applications of PIP (3:1) in lubricants and grease, there will be a five-year period until the prohibition takes place. Manufacturers of hard drives and other products with precision motors may be impacted, and should evaluate their supply chain to check for the presence of PIP (3:1).

  • The exclusion of the use of PIP (3:1) in motor vehicle parts has been removed and replaced with non-permanent exemptions. The exemptions expire in 15 years for new vehicles and parts for new vehicles (including heavy machinery), and expire in 30 years for replacement parts for vehicles and heavy machinery.
  • The exclusion of the use of PIP (3:1) in aerospace manufacturing has been removed and replaced with a 30-year exemption. Although the exemption has a 30-year applicability period, manufacturers supplying products and components to the aerospace industry may begin to see concern over the restriction sooner due to the long lifespans of aerospace products.
  • A 10-year exemption has been provided for the use of PIP (3:1) in manufacturing equipment as well as equipment used in the semiconductor industry.

Proposed changes for the use of PIP (3:1)

For PIP (3:1), a complete summary of the proposed revisions to the 2021 PBT final rule is provided below:

  • Require the use of PPE for the domestic manufacturing and processing of PIP (3:1) and some PIP (3:1)-containing products and articles, codifying existing practices, including at least a NIOSH-approved respirator with an APF of 10 and gloves that are chemically resistant to PIP (3:1);
  • Require the use of engineering controls and PPE for the use of PIP (3:1) as an intermediate in the manufacturing of cyanoacrylate adhesives, codifying existing practices, including at least a NIOSH-approved respirator with an APF of 50 and gloves that are chemically resistant to PIP (3:1);
  • Narrow the scope of the exclusion for lubricants and greases to aviation and turbine uses, with a 5-year phased-in prohibition for all other uses (as noted above);
  • Add new exclusions for use in wire harnesses and electric circuit boards (as noted above);
  • Replace the exclusion for new and replacement parts for motor vehicles with a 15-year phased-in prohibition for new parts and an additional 15 years for replacement parts (as noted above);
  • Replace the exclusion for new and replacement parts for aerospace vehicles with a 30-year phased-in prohibition for new parts and until the end of the service life of the vehicle for replacement parts (as noted above);
  • Extend the compliance timeframe for an additional 10 years for use in manufacturing equipment and in the semiconductor industry (as noted above);
  • Add a new 5-year compliance timeframe deadline for processing and distribution of PIP (3:1) for use as an inert ingredient in a Federal Insecticide, Fungicide, and Rodenticide Act-approved antifouling paint coating for U.S. Navy applications, and
  • Modify existing recordkeeping requirements and require records associated with the workplace protection requirements.

Proposed changes for the use of decaBDE

For decaBDE, a complete summary of the proposed revisions to the 2021 PBT final rule is provided below:

  • Require a label on existing plastic shipping pallets that are known to contain decaBDE;
  • Require the use of personal protective equipment (also referred to as “PPE”) for some activities involving decaBDE, codifying existing practices, including a NIOSH-approved N95 respirator with an assigned protection factor (APF) of 10 and gloves that are chemically resistant to decaBDE;
  • Prohibit releases to water during the manufacturing, processing, and distribution in commerce of decaBDE, decaBDE-containing products, and require all persons to follow any applicable regulations and best management practices for preventing the release of decaBDE;
  • Extend the compliance date for processing and distribution in commerce of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities;
  • Require export notification for decaBDE-containing wire and cable for use in nuclear power generation facilities; and
  • Modify existing recordkeeping requirements and require records associated with the workplace protection requirements.

Next steps and comment period

The proposed changes are currently in “pre-publication” status. The pre-publication of the updated rule has been provided for the convenience of interested parties. The EPA is expected to published the official version of the proposed rule in the Federal Register in the coming days.

The EPA will accept comments for a 45-day period after the proposed rule is posted to the Federal Register. During the comment period, interest parties can submit comments online by navigating to https://www.regulations.gov/ and searching for Docket Number EPA-HQ-OPPT-2023-0376. GreenSoft Technology will continue to track the development and progress of the regulation, and keep readers updated on our blog.

GreenSoft Technology strongly encourages companies impacted by these rules to utilize the 45-day comment period to submit any comments or questions to EPA.  Such input will allow EPA to take efforts to clarify any open concerns or questions prior to publication of the final rule.

GreenSoft Technology helps with TSCA supply chain data collection

GreenSoft Technology can help companies affected by the TSCA regulation by collecting substance data on all parts within their products to ensure that none of the restricted PBT substances are present.

As part of our TSCA data services, we will contact your supply chain to collect data on the presence of PIP 3:1, decaBDA, and/or all five PBT substances in your products. We will guide your suppliers to help them collect the necessary information that you need if they do not already have the information available.

We contact your suppliers as many times as it takes to obtain complete and accurate data, and provide you with compliance reports and substance analysis for your products, which you can use to ensure your products are in compliance with TSCA.

Contact us to learn more.

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PFAS

October 24, 2023 | Written by GreenSoft Technology, Inc.

U.S. Toxic Substances Control Act (TSCA) Final Rule on PFAS Published

TSCA-Section-8a7-PFASU.S. EPA publishes final rule for PFAS chemicals under TSCA Section 8(a)(7)

On October 11, the United States Environmental Protection Agency (EPA) published a new final rule on Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances, under Section 8(a)(7) of the Toxic Substances Control Act (TSCA).

With the addition of 40 CFR 705 to the US Federal Register, this new rule finalizes reporting and record-keeping requirements for the manufacture and import of Per- and Polyfluoroalkyl Substances (PFAS) under TSCA.  

Under the rule, any company that manufactures (including import) or has manufactured (including imported) PFAS or PFAS-containing articles in any year since January 1, 2011 are required to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards to the EPA.

The final rule is effective November 13, 2023. Affected companies will have 18 months following the effective date of the rule to report PFAS data to the EPA. Small manufacturers (as defined at 40 CFR 704.3) whose reporting obligations under this rule are exclusively from article imports will have 24 months from the effective date of the rule to report PFAS to the EPA.

More information from the EPA on the final rule can be found online. The full text of the final rule can be found here.

GreenSoft Technology helps identify PFAS chemicals in your supply chain for TSCA compliance

GreenSoft Technology’s Data Services solution provides affected companies with the chemical data from their supply chain that is needed to comply with the Section 8(a)(7) rule.

Our data collection team will contact your suppliers directly to obtain data on the PFAS chemicals contained in your products and components as per the PFAS definition noted in Section 8(a)(7).

With our Turnkey Service, we can generate the necessary compliance reports for you. Or you can use our GreenData Manager software to manage your company’s substance database and easily generate reports for this and other environmental regulations. Contact us to learn more.

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CE Mark

October 5, 2023 | Written by GreenSoft Technology, Inc.

UK Indefinitely Extends Recognition of CE Mark

Note: Further details and clarification on this blog post were published on December 5, 2023. View the updates here.

Companies may use either CE Mark or UKCA Mark for products sold in the United Kingdom

On August 1, the United Kingdom announced the indefinite recognition of the CE Mark beyond the previous 2024 deadline for transitioning to the UK Conformity Assessed (UKCA) mark.

The UK Department for Business and Trade (DBT) announced the decision as part of a wider package of “smarter regulations designed to ease business burdens and help grow the economy by cutting barriers and red tape.”

Businesses placing products on the UK market will now be able to continue the use of CE marking indefinitely, and have the choice to use either the CE Mark or the UKCA Mark to sell products in the UK. Previously, businesses were to fully transition to the UKCA product marking requirements by December 2024.

 

These updates apply to the 18 regulations that fall under the UK DBT. These are:

  • toys
  • pyrotechnics
  • recreational craft and personal watercraft
  • simple pressure vessels
  • electromagnetic compatibility
  • non-automatic weighing instruments
  • measuring instruments
  • measuring container bottles
  • lifts
  • equipment for potentially explosive atmospheres (ATEX)
  • radio equipment
  • pressure equipment
  • personal protective equipment (PPE)
  • gas appliances
  • machinery
  • equipment for use outdoors
  • aerosols
  • low voltage electrical equipment

Read the UK government announcement online.

GreenSoft Technology provides the data you need for product marking requirements

GreenSoft Technology provides Data Services to help companies with aspects of the CE marking and UKCA marking requirements. We collect and validate data from your supply chain to ensure your compliance with EU RoHS, EU REACH, UK RoHS, and other regulations. Contact us to learn more.

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EU POPs

October 4, 2023 | Written by GreenSoft Technology, Inc.

PFHxS Substances Added to EU POP Regulation

PFHxS officially listed as prohibited substances under EU POP Regulation

On August 8, the European Commission published an update to the EU Persistent Organic Pollutants (POP) regulation officially listing PFHxS and its salts and related substances (CAS No. 355-46-4 and others) as a prohibited substance. The restriction of PFHxS is effective August 28, 2023.

Perfluorohexane sulfonic acid (PFHxS) is a type of per- and polyfluoroalkyl substances (PFAS) compound, serving as a substitute for perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA).

In 2017, PFHxS and its salts were listed as Substances of Very High Concern (SVHC) under the EU REACH Regulation. In June of last year, PFHxS, its salts, and related compounds were also included in Annex A of the Stockholm Convention's list of persistent organic pollutants, without any exemptions.

This update increases the total number of entries on the prohibited substances list in Annex I of the EU POP Regulation to 29. Read the full text of the updated regulation online.

GreenSoft Technology helps to identify PFHxS and other PFAS chemicals in your supply chain

GreenSoft Technology’s Data Services solution provides affected companies with the chemical data from their supply chain that is needed to comply with the new updates to the EU POP Regulation and other PFAS restrictions around the globe.

Our data collection team will contact your suppliers to obtain data on the substances contained in your products and components. We’ll validate that data for accuracy and completeness, and check it against various government PFAS lists, and any other global environmental regulations that you must comply with.

With our Turnkey Service, we can generate the necessary compliance reports for you. Or you can use our GreenData Manager software to manage your company’s substance database and easily generate reports for this and other environmental regulations. Contact us to learn more.

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