EU Packaging Regulation

February 20, 2025 | Written by GreenSoft Technology, Inc.

Navigating the New EU Packaging Regulation: Key Changes for Electronics Manufacturers

New Packaging Regulation (EU 2025/40) Replaces existing Packaging Directive (94/62/EC)

On January 22, 2025, the EU Official Journal formally published Regulation (EU) 2025/40 on packaging and packaging waste. The Packaging and Packaging Waste Regulation (PPWR) will take effect August 12, 2026 and will replace the existing Packaging and Packaging Waste Directive (Directive 94/62/EC).  

Unlike its predecessor, which allowed for national variations in implementation, PPWR applies directly and uniformly across all EU member states. The regulation introduces stricter requirements on recyclability, reusability, and the restriction of hazardous substances, including per- and polyfluoroalkyl substances (PFAS). These changes will impact the entire supply chain, requiring companies to assess and adjust their packaging materials and compliance strategies. 


Key Changes in the New EU Packaging Regulation 

Limits on Heavy Metals

Article 5(4) of EU 2025/40 (PPWR) maintains the total concentration limit of 100 ppm for lead (Pb), cadmium (Cd), mercury (Hg), and hexavalent chromium (Cr(VI)) in packaging materials. This requirement remains unchanged from the previous directive.  


Potential Future Restrictions on Substances of Concern (SoC)

  • Article 6(4) directs the EU Commission to publish new supporting regulations which may introduce restrictions on substances of concern (SoC). The Commission is directed to adopt these new delegated acts by January 1, 2028.  
  • Substances of Concern includes EU REACH SVHCs, Persistent Organic Pollutants, as well as substances meeting certain hazard categories in Part 3, Annex VI of the EU CLP Regulation 
  • Substances which negatively affect the reuse and recycling of packaging materials are also considered SoCs for the purpose of this regulation. 

New PFAS Restrictions for Food-Contact Packaging

Article 5(5) sets strict limits on the presence of PFAS in food-contact packaging, prohibiting market placement if PFAS concentrations exceed: 

  • 25 ppb for individual PFAS tested using target analysis (excluding polymeric PFAS). 
  • 250 ppb for sum of individual PFAS, where applicable with prior degradation of precursors (excludes polymeric PFAS).  
  • 50 ppm for total PFAS, including polymeric PFAS. If total fluorine content exceeds 50 mg/kg, manufacturers must provide technical documentation (Annex VII) to demonstrate whether fluorine originates from PFAS or non-PFAS sources. 

The Commission will review whether to amend or repeal the PFAS restriction under the PPWR by August 2030. 


New Labelling and Marking Requirements

To enhance sorting and recycling, Article 12 mandates: 

  • A harmonized label indicating the material composition of packaging will be required by 12 August 2028, or 24 months after the new implementing acts noted above come into force, whichever is the latest, pursuant to Article 12(6) or 12(7). 
  • Standardized digital markings for packaging containing Substances of Concern (SoC) 
    • The standardized digital marking format will be defined by the upcoming delegated acts. The marking will include, at a minimum, the name and concentration of any SoC(s) present in each material within a packaging unit. 

Mandatory Recyclability and Reuse Standards

The previous directive promoted recycling but left implementation to national laws. PPWR enforces binding recyclability criteria, requiring electronics manufacturers to: 

  • Use packaging with a minimum recycled content. 
  • Meet reusability targets for certain packaging types. 

Increased Reporting and Compliance Obligations

Companies selling in the EU market must submit detailed packaging composition reports and demonstrate compliance with recyclability and reuse criteria. Stricter supply chain documentation will impact manufacturers sourcing packaging from multiple suppliers. 

Declaration of Conformity (DoC) Requirements: 

  • Per Article 39 & Annex VIII, manufacturers must provide a Declaration of Conformity (DoC) confirming that their packaging complies with the regulation.  
    • This document must include details to ensure traceability, such as packaging identification, manufacturer information, a statement of responsibility, relevant EU legislation and standards applied, and any certifications issued by a notified body (if applicable). 
  • If packaging or the packaged product falls under multiple EU regulations requiring a DoC, a single DoC may be prepared to cover all relevant Union acts. Alternatively, individual declarations may be compiled into a compliance dossier. 

PPWR's Impact on Electronics Manufacturers 

The new Packaging and Packaging Waste Regulation (PPWR) imposes additional compliance requirements. For electronics manufacturers, these changes mean: 

  • Technical documentation will be required for future SoC restrictions and labeling requirements. 
  • Manufacturers must reassess packaging materials for recyclability and compliance beginning in 2030 and beyond. 
  • Working closely with suppliers will be essential to obtain verified compliance documentation. 
  • Regulatory reporting processes must be updated to align with EU-wide standards. 

GreenSoft Can Help You Comply with the EU Packaging Regulation 

GreenSoft Technology provides supply chain data collection and compliance software to help electronics and component manufacturers navigate evolving environmental regulations like EU 2025/40 (PPWR) 

We offer proactive compliance solutions to: 

✔  Ensure your packaging meets recyclability and substance restrictions. 
✔  Streamline supplier documentation and compliance tracking. 
✔  Mitigate risks of non-compliance through expert regulatory support. 

Stay ahead of regulatory changes—contact us today to ensure compliance with the new EU Packaging Regulation! 

Recent Posts

Events

February 11, 2025 | Written by GreenSoft Technology, Inc.

Join GreenSoft Technology at the 47th Annual SESHA Symposium

SESHA 2025

Premier event for EHS professionals and semiconductor manufacturers

GreenSoft Technology will be exhibiting at the 47th Annual SESHA Symposium 2025 in Tempe, Arizona this coming April 14-17.

As a leading provider of environmental compliance data services for the electronics industry, we will be showcasing our PFAS Compliance Solution for semiconductor and component manufacturers at the event.

Additionally, on Tuesday, April 15, GreenSoft Compliance Specialist Randy Flinders will be presenting at the PFAS Regulatory Round Table. His session, titled Navigating PFAS Regulations: Current and Emerging Compliance Challenges for Semiconductor Manufacturers, will provide valuable insights into the latest regulatory developments and compliance strategies.


Why Attend SESHA Symposium 2025?

SESHA is the premier Environmental Health and Safety association serving the high technology and associated industries. This year’s symposium promises a week filled with technical content, professional development, and networking opportunities. Highlights include:

  • Technical Sessions: Gain insights from industry experts on the latest EHS trends and challenges.
  • Professional Development Courses: Enhance your skills with focused learning opportunities.
  • Exhibit Hall: Connect with top vendors in the EHS and semiconductor fields, including GreenSoft Technology.

Why PFAS Regulations Matter for Semiconductor Manufacturers and Component Manufacturers

As PFAS regulations continue to evolve worldwide, semiconductor and component manufacturers face significant challenges in ensuring compliance. Non-compliance can lead to penalties, product recalls, and restricted market access.

GreenSoft’s PFAS Compliance Solution takes a proactive approach by:

Our solution streamlines the compliance process, helping you reduce risk and focus on your core operations.


Learn more about our PFAS Compliance Solution for Semiconductor Manufacturers at SESHA

At the SESHA Symposium 2025, attendees will have the opportunity to learn more about our PFAS Solution and how GreenSoft can help semiconductor manufacturers and component manufacturers streamline their environmental compliance processes.

We invite you to visit our exhibit and speak with our team of experts to learn more about our services and how we can help your company reduce risk and prove compliance with all necessary regulations.

Register now to attend the SESHA Symposium 2025, or learn more about our PFAS Solution below.

Related Posts

Webinar

February 5, 2025 | Written by GreenSoft Technology, Inc.

WEBINAR: EU RoHS Exemption Renewals:
What Electronics Manufacturers Need to Know

EU RoHS exemption renewals 2025 webinar

Discover the status updates on key EU RoHS exemptions for electronics manufacturers

Join us for an insightful webinar on the recently published draft renewal decisions for key EU RoHS Annex III exemptions. These exemptions, including critical ones like 7(a), 7(c)-I, 7(c)-II, 6(a), 6(b), and 6(c), play a vital role in the electronics manufacturing industry.

With the final publication of these exemption status updates expected this year, this is a critical time for producers to understand how these changes could impact their compliance strategies.


What You’ll Learn

In this live webinar, Randy Flinders, Compliance Expert at GreenSoft Technology, will provide expert insights on:

  • Draft Renewal Decisions: A detailed breakdown of the newly proposed exemption renewals and sub-exemptions.
  • Impact on Your Products: How these changes could affect your compliance strategies and product lifecycles.
  • Timelines and Updates: Key details on the current draft status and the expected timeline for final adoption.

Plus, take advantage of a live Q&A session with Randy to get your most pressing compliance questions answered.


Reserve Your Spot Now

Space is limited, so register today to secure your seat at this essential webinar. Don’t miss the opportunity to stay ahead of regulatory changes and ensure your products remain compliant in 2025 and beyond.

Tuesday, March 11

Session 1:

7:00 AM PST / 10:00 AM EST / 3:00 PM CET

Session 2:

11:00 AM PST / 2:00 PM EST / 7:00 PM CET

Can’t attend live? No problem! Everyone who registers will receive a copy of the webinar recording.

Related Posts

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:

WEBINAR

EU RoHS Exemption Renewals 2025:

What Electronic Manufacturers Need to Know

Join us on March 11 for an insightful webinar exploring the new RoHS exemption renewal decisions, the timeline for their adoption, and the impact on your products.

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.

Related Posts

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.

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.

Related Posts

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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