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California Proposition 65

January 30, 2025 | Written by GreenSoft Technology, Inc.

One Chemical Added to California Proposition 65 Substance List

proposition-65Vinyl Acetate added to the California Prop 65 regulated substances list

In January, 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 January 3, 2025, Vinyl Acetate has been added to the list of chemicals known to the State of California to cause cancer. This listing was done via the “State’s Qualified Experts” mechanism, based on the Carcinogen Identification Committee’s (CIC) determination that this chemical was clearly shown to cause cancer. 

The warning requirement for significant exposures to this chemical will take effect on January 3, 2026.

Vinyl Acetate is used as a component in the production of polymers and copolymers, including "Ethylene Vinyl Acetate" (EVA), a polymer that acts as an encapsulating material for solar cells within solar panels. EVA is also used in wire insulation due to its flexibility and electrical insulating properties.

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 RoHS

January 29, 2025 | Written by GreenSoft Technology, Inc.

EU RoHS Exemption Renewals Published

RoHS Exemptions UpdateDraft Renewal Decisions for critical EU RoHS exemptions officially published

The European Commission has published draft renewal decisions for several EU RoHS Annex III exemptions, including critical exemptions such as 7(a), 7(c)-I, 7(c)-II, 6(a), 6(b), and 6(c).

Feedback on the draft delegated directives can be submitted until February 10, 2025, and any feedback submitted will be considered by the authorities when finalizing the draft delegated directives.

These EU RoHS Annex III exemptions, many of which are heavily applied and essential for electronics manufacturers, have been without effective expiry dates since requests for renewal were submitted as far back as November of 2019. These decisions have been long-awaited by industry, and producers are encouraged to review potential impacts to their products.

Summary of Draft Exemption Updates

The updates are complex, as some exemptions have been designated to be renewed, some designated as renewed with varying expiry dates under new application-specific exemptions, and some designated to not be renewed at all. Below is a summary of the changes:

Exemption 7(a): This exemption will remain in force in its current form until December 31, 2026, with specific more narrowly defined applications being additionally extended until December 31, 2027 by new exemptions 7(a)-I through 7(a)-VII.

Exemption 7(c)-I: This exemption will remain in force in its current form until December 31, 2026, with specific more narrowly defined applications being additionally extended until December 31, 2027 by new exemptions 7(c)-V and 7(c)-VI.

Exemption 7(c)-II: This exemption will remain in force until December 31, 2027.

Exemption 6(a): This exemption will not be renewed and will cease to be in force 12 months after the final delegated directive comes into force. However, Exemption 6(a)-I will be broken up into two exemptions – 6(a)-I and 6(a)-II, both of which will be in force until December 31, 2026.

Exemption 6(b): This exemption will not be renewed and will cease to be in force 12 months after the final delegated directive comes into force.

Exemptions 6(b)-I and 6(b)-II: These exemptions will not be renewed for product categories 1-7 and 10 and will cease to be in force 12 months [6(b)-I] or 18 months [6(b)-II] after the final delegated directive comes into force. However, these exemptions will remain in force for product categories 9 (industrial monitoring and control equipment) and 11 until December 31, 2026.

Additionally, a new Exemption 6(b)-III is provided which will expire December 31, 2026 and applies to product categories 1-8, 9 (other than industrial monitoring and control equipment), and 10.

Exemption 6(c): This exemption will remain in force until December 31, 2026.

 

The list of updated exemptions, their associated expiry dates, and links to the official draft delegated directives can be found in the table below:

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The list of updated exemptions, their associated expiry dates, and links to the official draft delegated directives can be found in the table below: 

Exemption

Description

Status

Product Category

Proposed Expiry Date

7(a)

(Link)

Lead in high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)

Renewed

All

Dec 31, 2026

7(a)-I

(Link)

Lead in high melting temperature type solders (i.e., lead-based alloys containing 85% by weight or more lead)

for internal interconnections for attaching die, or other components along with a die in semiconductor assembly with steady state or transient/impulse currents of 0.1 A or greater or blocking voltages beyond 10 V, or die edge sizes larger than 0.3 mm x 0.3 mm

New

All

Dec 31, 2027

7(a)-II

(Link)

Lead in high melting temperature type solders (i.e., lead-based alloys containing 85% by weight or more lead)

for integral (meaning internal and external) connections of die attach in electrical and electronic components, if all the following conditions are met:

- the thermal conductivity of the cured/sintered die attach material is >35W/(m*K),

- the electrical conductivity of the cured/sintered die attach material is >4.7MS/m ,

- solidus melting temperature is higher than 260°C

New

All

Dec 31, 2027

7(a)-III

(Link)

Lead in high melting temperature type solders (i.e., lead-based alloys containing 85% by weight or more lead)

in first level solder joints (internal or integral connections - meaning internal and external) for manufacturing components so that subsequent mounting of electronic components onto subassemblies (i.e. modules, sub-circuit boards, substrates, or point-to-point soldering) with a secondary solder does not reflow the first level solder. This sub-entry excludes die attach applications and hermetic sealings

New

All

Dec 21, 2027

7(a)-IV

(Link)

Lead in high melting temperature type solders (i.e., lead-based alloys containing 85% by weight or more lead)

in second level solder joints for the attachment of components to printed circuit board or lead frames:

1. in solder balls for the attachment of ceramic ball grid-array (BGA)

2. in high temperature plastic overmouldings (> 220 °C)

New

All

Dec 31, 2027

7(a)-V

(Link)

Lead in high melting temperature type solders (i.e., lead-based alloys containing 85% by weight or more lead)

as a hermetic sealing material between:

1. a ceramic package or plug and a metal case,

2. component terminations and an internal sub-part

New

All

Dec 31, 2027

7(a)-VI

(Link)

Lead in high melting temperature type solders (i.e., lead-based alloys containing 85% by weight or more lead)

for establishing electrical connections between lamp components in incandescent reflector lamps for infrared heating, high intensity discharge lamps, or oven lamps

New

All

Dec 31, 2027

7(a)-VII

(Link)

Lead in high melting temperature type solders (i.e., lead-based alloys containing 85% by weight or more lead)

for audio transducers where the peak operating temperature exceeds 200°C

New

All

Dec 31, 2027

7(c)-I

(Link)

Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound

Renewed

All

Dec 31, 2026

7(c)-II


(Link)

Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher excluding applications covered by point 7(c)-I or 7(c)-IV

Renewed as modified

All

Dec 31, 2027

7(c)-V

 

(Link)

Electrical and electronic components containing lead in a glass or glass matrix compound that fulfils any of the following functions:

1) for protection and electrical insulation in glass beads of high-voltage diodes and glass layers for wafers on the basis of a lead-zinc-borate or a lead-silica-borate glass body;

 

2) for hermetic sealing between ceramic, metal

and/or glass parts;

 

3) for bonding purposes in a process parameter

window for < 500 °C combined with a viscosity of 1013.3 dPas (‘glass-transition temperature’);

 

4) for use as a resistive material such as ink, with a resistivity range from 1 ohm/square to 1

megohm/square, excluding trimmer potentiometers;

 

5) for use in chemically modified glass surfaces for microchannel plates (MCPs), channel electron multipliers (CEMs) and resistive glass products (RGPs).

New

All

Dec 31, 2027

7(c)-VI

 

(Link)

Electrical and electronic components containing lead in a ceramic that fulfils any of the following

functions (excluding items covered by points 7(c)-II, 7(c)-III and 7(c)-IV, as well as point 14

of Annex IV)

1) for use in piezoelectric lead zirconium titanate (PZT) ceramics;

2) for providing ceramics with a positive temperature coefficient (PTC).’

New

All

Dec 31, 2027

6(a)

 

(Link)

Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0,35 % lead by weight

Not Renewed

All

12 months after final delegated directive comes into force

6(a)-I

 

(Link)

Lead as an alloying element in steel for machining purposes containing up to 0,35 % lead by weight*

Renewed as modified

All

Dec 31, 2026

6(a)-II

 

(Link)

Lead as an alloying element in batch hot-dip

galvanised steel components containing up to 0,2% lead by weight*

New

All

Dec 31, 2026

6(b)

 

(Link)

Lead as an alloying element in aluminium containing up to 0,4 % lead by weight

Not Renewed

All

12 months after final delegated directive comes into force.

6(b)-I

 

(Link)

Lead as an alloying element in aluminium containing up to 0,4 % lead by weight, provided it stems from lead-bearing aluminum scrap recycling*

Not Renewed

1-7 and 10

12 months after final delegated directive comes into force.

Renewed

9 (industrial) and 11

Dec 31, 2026

6(b)-II

 

(Link)

Lead as an alloying element in aluminium for machining purposes with a lead content up to 0,4 % by weight*

Not Renewed

1-7 and 10

18 months after final delegated directive comes into force.

Renewed

9 (industrial) and 11

Dec 31, 2026

6(b)-III

 

(Link)

Lead as an alloying element in aluminium casting alloys containing up to 0,3% lead by weight provided it stems from lead-bearing aluminium scrap recycling*

New

1-8, 10, and 9 (other than industrial)

Dec 31, 2026

6(c)

 

(Link)

Copper alloy containing up to 4 % lead by weight*

Renewed

All

Dec 31, 2026

*The exemption shall not cover EEE for supply to the general public where the EEE or accessible part thereof may, during normal or foreseeable conditions of use, be placed in the mouth by children. However, the exemption shall apply where the following can be both demonstrated:

— the rate of lead release from such an EEE or any accessible part, whether coated or uncoated, does not exceed 0,05 μg/cm2 per hour (equivalent to 0,05 μg/g/h),

— for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the EEE.

(For the purpose of this footnote, it is considered that an EEE or accessible part of an EEE may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size.)

What’s Next?

According to the EU Commission’s website, the newly published delegated directives will be subject to a 4-week public feedback period while also being notified to the WTO Technical Barriers to Trade Committee (60 days). The Delegated Directive will then be adopted by the Commission.

The two-month scrutiny period of the European Parliament and the Council then commences (an extension of the scrutiny period on request is possible). After this scrutiny period, in case of no objections from the co-legislators, the Delegated Directive will be published in the Official Journal.

Can these exemptions be subject to new renewal requests?

As noted in Article 5(5) of EU RoHS Directive 2011/65/EU, an application for exemption renewal cannot be made any later than 18 months before the exemption expires. This means any renewal requests for exemptions which expire December 31, 2026 must be submitted by June 30, 2025.

Considering the publication schedule noted above, and that new requests cannot be submitted until these delegated directives are in force, time is limited. Stakeholders who intend to submit requests for any exemptions designated to expire in December 2026 should start working on their dossier(s) for exemption renewal now.

Exemptions which expire on December 31, 2027 have a little more time; those submissions will need to be made by June 30, 2026. For exemptions that have not been renewed and expire 12 or 18 months after the delegated directives come into force, applications for renewal are not possible.

GreenSoft can help with EU RoHS compliance

With the status and timing of EU RoHS exemptions regularly being updated, keeping track of the various expiration dates and current exemptions is a complicated task. Companies should prepare and plan for a time when they can no longer apply such exemptions, as the exemptions could expire as soon as 12 months after the European Commission's exemption review decision if the exemption is not renewed, as demonstrated by the renewal actions outlined above.

EU RoHS compliance is mandatory for affected companies that manufacture or distribute products in the European market. Failure to comply with EU RoHS 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 help electronics manufacturers with EU RoHS compliance. We’ll collect data on the chemicals contained in your products so that you can ensure you’re complying with the EU RoHS Directive.

Additionally, GreenSoft Technology maintains a compiled list of the EU RoHS Exemptions in order to perform EU RoHS Data Services for our customers and to keep our GreenData Manager software up-to-date. We also make this list available online to the public for your convenience and reference. You can download the updated EU RoHS Exemptions List here.

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

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EU REACH

January 23, 2025 | Written by GreenSoft Technology, Inc.

5 Substances Added and an Update to EU REACH SVHC List

eu-reach-svhcFive substances have been added to EU REACH SVHC Candidate List, and one substance update

On January 21, the European Chemicals Agency (ECHA) added five chemicals to the Substances of Very High Concern (SVHC) Candidate List under the EU REACH Regulation. ECHA also updated one existing entry on the SVHC list.

This action brings the EU REACH SVHC Candidate List to 247 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.

The 5 new substances are listed in the table below:

 

Substance Name

EC Number

CAS Number

Reason for Proposing

Examples of uses

6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

701-118-1

2156592-54-8

Toxic for reproduction (Article 57c)

Lubricants, greases, release products and metal working fluids

O,O,O-triphenyl phosphorothioate

209-909-9

597-82-0

Persistent, bioaccumulative and toxic, PBT
(Article 57d)

Lubricants and greases

Octamethyltrisiloxane

203-497-4

107-51-7

Very persistent, very bioaccumulative, vPvB
(Article 57e)

Manufacture and/or formulation of: cosmetics, personal/health care products, pharmaceuticals, washing and cleaning products, coating and non-metal surface treatment and in sealants and adhesives

Perfluamine

206-420-2

338-83-0

Very persistent, very bioaccumulative, vPvB
(Article 57e)

Manufacture of electrical, electronic and optical equipment and machinery and vehicles

Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives

421-820-9

192268-65-8

Persistent, bioaccumulative and toxic, PBT
(Article 57d)

Additives in lubricants and hydraulic fluids

The one updated entry is listed in the table below:

Substance Name

EC Number

CAS Number

Reason for Proposing

Examples of uses

Tris(4-nonylphenyl, branched and linear) phosphite (TNPP)

-

-

Endocrine disrupting properties (Article 57(f) – environment)

Polymers, adhesives, sealants and coatings

ECHA’s announcement of the additions and update can be found here. The full SVHC-247 list can be found here. The last prior addition to the SVHC list was SVHC-242 in November 2024.

GreenSoft can help with EU REACH compliance

The EU REACH Restricted Substances 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 21, 2025 | Written by GreenSoft Technology, Inc.

Maine Proposes Final Text for PFAS Regulation

PFAS notification requirements go into effect January 2026; PFAS ban goes into effect January 2032

On December 20, 2024, the Maine Department of Environmental Protection (DEP) published the final proposed text of the state’s PFAS regulation.

Maine’s bill regulating the selling of per- and polyfluoroalkyl substances (PFAS), or “forever chemicals,” in the state of Maine was signed into law on April 16, 2024, and comes into effect in January 2026.

Per the final regulation proposal, a PFAS reporting mandate will take effect on January 1, 2026, which will require manufacturers of products sold in Maine which contain intentionally-added PFAS to report details on the product and it’s PFAS content to the DEP. 

And effective January 1, 2032, the rule moves from a reporting requirement to a PFAS ban. From this date, any products that contain intentionally added PFAS may not be sold, offered for sale, or distributed for sale in Maine, unless the DEP determines by rule that the use of PFAS in the product is a currently unavoidable use.

Currently unavoidable use (“CUU”), exemptions, and the effects on electronic equipment

The PFAS ban will take effect January 1, 2032 for any products that contain intentionally added PFAS unless the DEP determines that the use of PFAS in the product is a currently unavoidable use. The DEP will accept proposals for currently unavoidable use (“CUU”) determinations. Manufacturers may individually or collectively submit proposals to PFASProducts@maine.gov. A separate proposal must be submitted for each individual combination of product category and the associated industrial sector. Details on the contents of what should be included in each proposal can be found under section 9.A of the proposed text.

The proposed regulation includes exemptions for federal preemption (including products meeting the standards or requirements of the FAA, NASA, DOD, or DHS), certain product packaging, used products or components, firefighting or fire-suppressing foams, certain medical prosthetics or orthotic devices and drugs regulated under the FDA, certain veterinary products regulated under the FDA, environmental or water testing devices, motor vehicles regulated under federal motor vehicle safety standards, watercrafts or seaplanes, semiconductors*, and non-consumer electronics and non-consumer laboratory equipment. These exemptions cover both the products, and equipment directly used in the manufacture of these products.

*The text of the semiconductor exemption states:

Chapter 90: 4.A (11): “A semiconductor, including semiconductors incorporated into electronic equipment, and equipment and materials used in the manufacture of semiconductors;

NOTE: While semiconductors incorporated into electronic equipment are exempted from this Chapter, electronic equipment in their entirety is not. Manufacturers of electronic equipment are still subject to sales prohibitions, currently unavoidable use determinations, and notification requirements on the balance of their product which is not comprised of semiconductors.”

The fact sheet and full text of the proposed rule can be found online here. GreenSoft maintains a PFAS Resource Center with up-to-date information about PFAS regulations around the globe here.

visit the pfas resource center

GreenSoft Technology offers a PFAS compliance solution for manufacturers

GreenSoft Technology’s PFAS Data Services solution provides affected companies with the chemical data from their supply chain that is needed to comply with the Maine PFAS regulation as well as other PFAS regulations around the globe.

Our data collection team will contact your suppliers to obtain data on the PFAS chemicals and other substances contained in your product and components. We’ll validate that data and check it for accuracy and completeness. 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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EU RoHS

January 16, 2025 | Written by GreenSoft Technology, Inc.

Understanding the RoHS Recast, RoHS-3, and the CE Mark

A comprehensive guide to RoHS Compliance and CE Marking requirements for electronics manufacturers

For manufacturers, importers, and distributors of electrical and electronic equipment (EEE) in the European Union, compliance with the Restriction of Hazardous Substances (RoHS) Directive is crucial for market access.

This guide explores the RoHS Recast, RoHS-3, and the significance of the CE Mark, providing a clear pathway to understanding the regulations and achieving RoHS compliance.

What is RoHS compliance?

RoHS compliance ensures that products follow EU rules limiting certain hazardous materials in electrical and electronic equipment (EEE). Created in 2002, the original RoHS Directive restricts the amount of specific heavy metals (lead, mercury, cadmium, and hexavalent chromium) as well as certain brominated compounds which have been found to be harmful to human health and the environment. Meeting the requirements of the EU RoHS directive makes products safer and helps reduce environmental impact.

Products that meet these standards are considered RoHS compliant, meaning they contain little or no restricted substances.  Most EEE must meet the requirements of the RoHS directive in order to be placed on the EU market.

The RoHS Recast and the CE Mark

While the RoHS Recast (RoHS-2) applies to the original 8 categories of the EU RoHS Directive, the recast expanded the scope of the regulation to include additional product categories, including medical devices and monitoring and control instruments since July 2014, in-vitro medical devices since July 2016, and industrial monitoring and control equipment since July 2017. All remaining categories of EEE came into scope in July of 2019, unless specifically excluded by article 2 of the directive.

RoHS-2 compliance is required in order to apply the CE mark, which allows the device to be placed in the EU market. The EU RoHS directive (in most cases) is a self-certification endeavor, with producers ensuring compliance before listing the regulation on the product’s EU Declaration of Conformity and applying the CE-Mark. To assist producers in determining due diligence requirements when evaluating compliance, authorities have published IEC EN 63000 , which defines risk analysis and documentation requirements.

The RoHS Recast, often referred to as RoHS-2, is an update to the original RoHS Directive, expanding its scope and adding new compliance requirements. While the first RoHS Directive focused on eight categories of EEE, RoHS-2 added new product types to ensure a broader impact. Here’s a quick look at these additions:

  • Medical Devices: Included under RoHS compliance since July 2014, bringing safety and environmental protection to a critical industry.
  • Monitoring and Control Instruments (non-industrial) since July 2014.
  • In-Vitro Medical Devices: Added in July 2016, furthering compliance requirements in the medical sector.
  • Industrial Monitoring and Control Equipment: Included as of July 2017, ensuring that more specialized and high-tech equipment is also subject to RoHS standards.
  • All other categories of electrical and electronic equipment not included in the pervious categories as of July 2019.

Electrical and electronic products required to carry the CE Mark for EU market access must also demonstrate EU RoHS compliance if they fall within the scope of EU RoHS. The CE Mark indicates that a product meets all applicable EU regulations, including EU RoHS when relevant. As part of validating compliance with the EU RoHS-2 directive, manufacturers are encouraged to ensure their products meet the requirements of IEC EN 63000, which specifies certain documentation practices for EU RoHS compliance:

  • Risk analysis: Producers must determine the risk of restricted substances being present in materials, parts, and sub-assemblies used to construct EEE, and also evaluate the trustworthiness of material suppliers who provided data to support RoHS compliance.
  • Technical Documentation: The types of data needed to determine compliance are outlined. These files should include supplier declarations or contractual agreements, material declarations, and analytical test results. The type of data collected is determined by the results of the risk analysis results.
  • Periodic Review: Documentation should be reviewed periodically to ensure that they are still valid and that the technical documentation reflects any changes to materials, parts or subassemblies.

Is RoHS-3 in effect yet?

In 2015, four Phthalate substances were added to the restricted substances list under Annex II of RoHS-2, and took effect in 2019 or 2021 depending on the type of equipment. The RoHS-2 regulation with the four new substances is sometimes referred to within the industry as "RoHS-3," although it is still officially considered the RoHS-2 regulation by the European Commission.

At some point in the future, the European Commission will recast the RoHS Directive, and that updated version of the RoHS Directive will officially be “RoHS-3.”

GreenSoft has created a video explaining the difference between RoHS-2 and RoHS-3 here.

GreenSoft can help with EU RoHS compliance

EU RoHS compliance is mandatory for affected companies that manufacture or distribute products in the European market. Failure to comply with EU RoHS 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 help electronics manufacturers with EU RoHS compliance. We’ll collect data on the chemicals contained in your products so that you can ensure you’re complying with the EU RoHS Directive.

Additionally, GreenSoft Technology maintains a compiled list of the EU RoHS Exemptions in order to perform EU RoHS Data Services for our customers and to keep our GreenData Manager software up-to-date. We also make this list available online to the public for your convenience and reference. You can download the updated EU RoHS Exemptions List here.

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

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EU RoHS

January 13, 2025 | Written by GreenSoft Technology, Inc.

Plan to Add Two New Substances to EU RoHS Officially Abandoned

Proposal to add MCCPs and TBBP-A to EU RoHS Directive terminated

On December 10, 2024, the European Commission announced that a plan to add two substances to the EU RoHS Directive has officially been abandoned.

In September 2022, the European Commission began reviewing a consultant report by the Oeko-Institut which recommended adding two new substances for restriction under the EU RoHS Directive.

The two substances which were under consideration are:

  • Medium chain chlorinated paraffins (MCCPs)
  • Tetrabromobisphenol A (TBBP-A)

MCCPs are used in electrical and electronic equipment (EEE) mostly as constituents of PVC insulations for electric cables and wires and other soft plastic or rubber components, including polyurethane, polysulphide, acrylic and butyl sealants.

The primary use of TBBP-A is as a precursor in the production of brominated epoxy resins that function as reactively flame-retarded substrate in printed wiring boards (PWB). It is also used as an additive flame retardant in thermoplastic EEE components, for example housings that consist of ABS plastic.

After reviewing the report, the European Commission decided not to add these two substances to the EU RoHS Directive. The announcement of the official abandonment of the plan can be found online.

GreenSoft can help with EU RoHS compliance

GreenSoft Technology provides Data Services and GreenData Manager software to help electronics manufacturers with EU RoHS compliance. We’ll collect data on the chemicals contained in your products so that you can ensure you’re complying with the EU RoHS Directive.

Additionally, GreenSoft Technology maintains a compiled list of the EU RoHS Exemptions in order to perform EU RoHS Data Services for our customers and to keep our GreenData Manager software up-to-date. We also make this list available online to the public for your convenience and reference. You can download the updated EU RoHS Exemptions List here.

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

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California Proposition 65

January 8, 2025 | Written by GreenSoft Technology, Inc.

California Amends Proposition 65 Warning Label Requirements

proposition-65Amendment requires short-form warning labels under California Proposition 65 to list at least one chemical name

On December 6, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) officially adopted an amendment to the short-form warning label requirements under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).

The most critical impact to product producers initiated by this amendment is the new requirement to include the name of substance(s) at risk for unsafe exposure in the Proposition 65 short-form warning. Previously, the short-form warning did not require the substance name to be disclosed. This change is shown in the example labels below.

Other significant changes include clarifying warning requirements for products sold online and in catalogs, a new allowance to optionally use “CA WARNING” or “CALIFORNIA WARNING” on the Proposition 65 label in place of “WARNING”, and new specific warning verbiage applicable to passenger, off-highway vehicle or recreational marine vessel parts.

The new rule is effective January 1, 2025, but stipulates that any products manufactured and labeled prior to January 1, 2028 may use the existing short-form label requirements. Any products manufactured and labeled after January 1, 2028 must use the new short-form label requirements, which are detailed below.

The announcement for the new rule can be found here, and the full text of the amended rule can be found here. The amendment has been under development since December 2021. The latest text was proposed in October 2023 and has now been officially adopted in December 2024.

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.

OEHHA was concerned that this led to overuse of the warning. As a result, OEHHA sought to end this practice with this new amendment. Under this new amendment, product producers will be required to disclose at least one specific substance 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 present a risk of unsafe exposure.

Example of a current short-form warning label (without chemical names included): This short-form warning can be used on a product manufactured and labeled prior to January 1, 2028, regardless of when the product is sold to a consumer.

Examples of the new short-form warnings required on products manufactured and labeled after January 1, 2028 (with chemical names included) – various verbiage options are available:

GreenSoft Technology provides help with Proposition 65

Complying with CA 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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Market Access

December 16, 2024 | Written by GreenSoft Technology, Inc.

52 Products Recalled from European Market, Found not RoHS Compliant

eu-rohs-violation-recalls52 products lose European market access due to EU RoHS Directive and Persistent Organic Pollutant violations.

In the fourth quarter of 2024, importers of 52 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 Persistent Organic Pollutant (POP) Regulation, and one product was also found to be non-compliant with the EU REACH 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 not be RoHS compliant must be removed from the European market due to environmental concerns.

Products recalled in the fourth quarter of 2024 include a wireless speaker, Wi-Fi camera, mini projector, and a head lamp.

The recalls were announced via EU Safety Gate alerts. Below are 3 of the 52 total enforcement actions for this quarter.

 

Essential oil diffuser

Description:

The solders in the products and a sensor have an excessive concentration of lead. (measured values up to 20.2% and 11.8% by weight respectively). Lead poses a risk to the environment. The plastic material of the cable has an excessive concentration of bis(2-ethylhexyl) phthalate (DEHP) and dibutyl phthalate (DBP) (measured values up to 0.38 % and 2.8% by weight, respectively). These phthalates pose a risk to human health and the environment.

Regulation Violation(s):

EU RoHS 2 Directive

Alert Number/Link:

A12/03303/24

Smartwatch for Kids

Description:

The solders in the product have an excessive concentration of cadmium (measured value up to 0.36% by weight). Cadmium bio-accumulates and poses a risk to the environment.

Regulation Violation(s):

EU RoHS 2 Directive

Alert Number/Link:

A12/03304/24

Mirror with LED

Description:

The solders in the product have an excessive concentration of lead. (measured value: up to 64 % 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 1.8 %, 0.3 % and 5.8 % by weight, respectively). Lead poses a risk to the environment. DEHP and DBP pose a risk to human health and the environment. 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 Directive

Persistent Organic Pollutant (POP) Regulation

Alert Number/Link:

A12/03495/24

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

Compliance with the EU RoHS directive and the Persistent Organic Pollutant (POP) regulation is mandatory for affected companies that manufacture or distribute products in the European market. As demonstrated by the RoHS testing and subsequent 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 stay RoHS compliant so that you can ensure you retain market access in the European market.

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

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EU REACH

November 13, 2024 | Written by GreenSoft Technology, Inc.

One Entry Added to EU REACH SVHC List

eu-reach-svhcEU REACH SVHC List now contains 242 Entries

On November 7, the European Chemicals Agency (ECHA) announced the addition of 1 substance to the EU REACH Substances of Very High Concern (SVHC) Candidate List.

The new substance, Triphenyl Phosphate, as well as its reason for inclusion and common uses, is listed in the table below.

The EU REACH SVHC Candidate List now has 242 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.

The new substance is:

Substance Name

EC Number

CAS Number

Reason for Inclusion

Examples of use(s) in Electronics

Triphenyl Phosphate

204-112-2

115-86-6

Endocrine disrupting properties (Article 57(f) - environment)

This substance is used as a flame retardant and plasticiser in polymer formulations, adhesives, and sealants.

ECHA’s discussion on including the substance was originally foreseen for June, but it was delayed due to substantial new information becoming available on its properties.

ECHA’s announcement of the additions can be found here. The full SVHC-242 list can be found here. The last prior addition to the SVHC list was SVHC-241 in June 2024.

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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Toxic Substances Control Act (TSCA)

November 12, 2024 | Written by GreenSoft Technology, Inc.

EPA Publishes Final Rule Amending PBT Chemical Restrictions Under TSCA

TSCAPhase-in prohibitions and exclusions for certain uses of PIP (3:1) and DecaBDE published

On October 31, 2024, the U.S. Environmental Protection Agency (EPA) released a pre-publication notice of revisions to existing rules for Persistent, Bioaccumulative, and Toxic (PBT) chemicals regulated under the U.S. Toxic Substances Control Act (TSCA).

This new “final rule” addresses implementation issues affecting the supply chains of various industry sectors, including nuclear energy, transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production, by revising compliance dates for certain uses of PIP (3:1) and DecaBDE.

The final rule amends phase-in prohibitions and exclusions on processing and distribution for certain uses and further extends the compliance dates for some articles used in consumer electronic equipment, commercial electronic equipment, heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, power generating equipment, laboratory equipment, and manufacturing equipment, including manufacturing equipment used in the semiconductor industry.

However, the EPA is not revising the October 31, 2024 compliance date for articles not otherwise covered by (1) an exclusion from prohibition or (2) an existing or newly finalized extension to a phase-out compliance deadline.

The amended phase-in prohibitions and exclusions are effective 60 days after the final rule is published in the Federal Register. EPA intends to focus its enforcement on ensuring compliance with the requirements of this final rule.

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.

Where to Find the Regulation Text

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 newly amended rule. Changes affecting electronic equipment include, but are not limited to:

  • PIP 3:1 and DecaBDE prohibitions and restrictions no longer apply to products or articles containing the substance at concentrations less than 0.1 percent by weight, if the PIP (3:1) or DecaBDE was not intentionally added to the product or article.

  • While the use and processing of PIP 3:1 is prohibited as of October 31, 2024, operators can continue to distribute PIP 3:1 containing articles in commerce until October 31, 2026.

  • A permanent exclusion has been provided for the use of PIP (3:1) in containing products for use in circuit boards and wire harnesses, including but not limited to terminal and fuse covers, cable sleeves, casings, connectors and tapes, and PIP (3:1)-containing circuit boards and wire harnesses including but not limited to terminal and fuse covers, cable sleeves, casings, connectors and tapes. 

    • As such, many electronic components will no longer be in scope for TSCA PIP 3:1 prohibition. However, this applies to PCB and cable assemblies only. Enclosures, pumps, motors, fasteners, and other items which are not specifically intended to be used on a circuit board remain in scope.
  • For PIP (3:1) applications in replacement parts for consumer electronic equipment, there will be a 7-year period until the prohibition takes place.
  • 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 15 year period until the prohibition takes place.
  • The exclusion of the use of PIP (3:1) in motor vehicle (including motorized heavy machinery) 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.

  • The use of PIP (3:1) in parts for new manufacturing equipment, including in the semiconductor industry, new heating, ventilation, air-conditioning, refrigeration, and water-heating equipment, new power generating equipment, new laboratory equipment, as well as new commercial electronic equipment is allowed under a new phase-in exemption. The exemption expires in 10 years for new parts.  Replacement parts are allowed until the end of the manufacturing and laboratory equipment service lives, or for 25 years, based on equipment type.

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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EU CLP

October 23, 2024 | Written by GreenSoft Technology, Inc.

EU Classification, Labelling and Packaging of Chemical Substances (CLP) Regulation Update

CLP updates modify the existing regulation to clarify rules and broaden scope

On October 14, the European Council adopted a new amendment to the regulation on the classification, labelling and packaging of chemical substances (CLP).

The CLP regulation amendment is an update of the existing 2008 EU legislation. The amendment clarifies the rules on labelling chemical substances, and adapts them to different forms of trade (such as online trade or bulk sales at refill stations).

The updated regulation clarifies that the CLP regulation also applies to online sales, including purchases in digital marketplaces, and sets out the scope of the regulation for harmonized classification of substances in all physical states.

It requires that most chemical products bear a physical label while the digital label may also be an option for suppliers. It also introduces measures to make the labels clearer and easier to read in particular for people with sight difficulties.

The regulation will enter into force 20 days after it is signed by the President of the European Council and published in the Official Journal of the European Union.

Read the full text of the CLP amendment here. Read the press release announcement of the new amendment here.

GreenSoft can help with product compliance

GreenSoft Technology offers Data Services to help electronics and other manufacturers comply with environmental regulations such as the CLP regulation. Our team provides data collection, data validation, and materials analysis, as well as GreenData Manager (GDM) software for substance calculations and report generation.

Learn more about how our Data Services and GDM Software can streamline your product compliance by contacting us.

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Webinar

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

EU Regulatory Update for Electronics Producers 2024 Webinar Recording

 

Get the Latest Updates on Regulations in the EU Impacting Electronics Manufacturers

On October 3, GreenSoft Technology hosted an educational webinar covering critical updates on Regulations out of the European Union impacting electronics producers. View a recording of the webinar now in our Webinar Archive.

Ensure your company is up to date with EU environmental regulations affecting electronics manufacturers in 2024. Led by industry expert Randy Flinders, Compliance Specialist for GreenSoft Technology, this webinar provides an in-depth overview of the key changes and new developments to major EU regulations, including:

  • EU RoHS Exemptions Updates
  • EU Persistent Organic Pollutants Regulation Update
  • EU REACH Update
  • EU Proposed PFAS Ban Update
  • Other significant EU Regulations impacting electronics manufacturers

Whether you're seeking clarity on regulatory compliance or striving to stay ahead of the curve in environmental responsibility, don't miss the opportunity to watch this webinar in our Webinar Archive.

WATCH THE WEBINAR
 

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