Amended RoHS Directive to Include Phthalates Comes into Effect for Medical Device Manufacturers

As of July 22nd 2021, medical device manufacturers must be able to demonstrate compliance to the delegated RoHS Directive 2015/863/EU to include the four RoHS phthalates BBP, DEHP, DBP, and DIBP. The delegated RoHS Directive in an amendment to RoHS 2 (Directive 2011/65/EU), which originally restricted six substances used in the manufacture of many types of electronic and electrical equipment (EEE).

Together, the ten substances listed below have been found to be hazardous to the environment and dangerous in terms of occupational exposure that can occur during the manufacture and disposal of EEE.

RoHS 2 (2011/65/EU)

Lead (Pb)

Mercury (Hg)

Cadmium (Cd)

Hexavalent Chromium (Cr6+)

Polybrominated biphenyl (PBB)

Polybrominated diphenyl ether (PBDE)

RoHS 2 (2015/863/EU)

Benzyl butyl phthalate (BBP)

Bis (2-ethylhexyl)phthalate (DEHP)

Dibutyl phthalate (DBP)

Diisobutyl phthalate (DIBP)

The four phthalates added to the RoHS Directive are most often used as plasticizers, which are substances that are added to materials to increase flexibility and reduce brittleness. These RoHS-regulated plasticizers are commonly found in PVC, adhesives, inks, and acrylics and are also found on the REACH SVHC Candidate List due to their endocrine-disrupting properties.

Some examples of medical devices which are now required to be RoHS compliant (to include the four phthalates are:

Blood pressure meters

Defibrillators

Dental equipment

Dialysis equipment

Hearing aids

Intravenous drug infusion pumps

Medical lasers

Oxygen analyzers

Surgical microscopes

Ventilators

X-ray devices

Total Parts Plus has pre-emptively worked to obtain RoHS compliance to include BBP, DEHP, DBP, and DIBP for all our medical customers, and continues to have an extensive and ever-expanding compliance database covering EU RoHS, EU REACH, Conflict Minerals, Prop 65, POPs, material declarations, and more. Reach out to our team of industry and regulatory experts today to request a demonstration of our suite of compliance software tools.

ParkerGale and Glenn Trout Take Majority Stake in Supply Chain Compliance Companies

ParkerGale Capital and Chief Executive Officer Glenn Trout acquire and merge software companies Source Intelligence and Total Parts Plus to create supply chain compliance software leader.

July 7, 2021 | Chicago, IL: ParkerGale Capital, a Chicago-based private equity firm that specializes in investing in profitable software companies to accelerate growth, and industry veteran Glenn Trout announce their majority investment in Source Intelligence, the industry-leading SaaS company providing compliance data on supply chains for nearly 100 global regulations, and Total Parts Plus (TPP), the leading provider of critical parts data for product environmental compliance and lifecycle management. As part of the partnership, Source Intelligence will merge with Total Parts Plus and Glenn Trout will become Chief Executive Officer of the combined businesses. Previously, Glenn was the Founder and CEO of VelocityEHS, the leader in Environmental, Health & Safety (EHS) software.

For over a decade, Source Intelligence has delivered the leading supply chain transparency and supplier performance software platform that supports nearly 100 global regulations including corporate sustainability, regulatory compliance, and social responsibility initiatives. For over 20 years, TPP has combined web tools, data, and managed research to provide a comprehensive solution for obsolescence management, REACH and RoHS, and Conflict Minerals compliance.

The combination of Source Intelligence and TPP will give our customers access to one of the most expansive supplier networks and parts & compliance libraries in the industry. TPP’s data collection and validation services along with Source Intelligence’s suite of software tools provide a comprehensive solution for data analysis and compliance reporting.

“Both Source Intelligence and TPP are very excited to be working together moving forward. Together, we have the resources and expertise to support our rapid growth, provide enhanced services to our customers, and combine our supplier networks to create one of the largest databases in the industry,” says Glenn Trout who is joining the combined companies as Chief Executive Officer. “I’ve had the pleasure of working alongside both Source Intelligence and TPP and have seen firsthand their passion and drive to provide customers with the best technology solutions for supply chain transparency. Our vision is to leverage the strengths of both teams to make supply chain data management and compliance easy and accessible for both small and large enterprises.”

Devin Mathews, Partner at ParkerGale concludes on the new partnership and expanded resources, “We have known Glenn Trout for over a decade, and we’re thrilled to have him leading the combined team. Through our research, it was clear the combination of these two complementary companies could be powerful for companies struggling to stay on top of rapidly changing global regulatory requirements. We couldn’t be more excited to be partnering with Glenn and the team to bring these two growing companies together.”

About Source Intelligence: Source Intelligence is the leading provider of SaaS Supply Chain Compliance solutions and has been automating supply chain compliance for over a decade. Source Intelligence uses AI and machine learning technology to gather and validate supply chain data for over 300,000 companies for due diligence, regulatory compliance, risk management, and ESG initiatives. To learn more, visit www.sourceintelligence.com.

About Total Parts Plus: Total Parts Plus specializes in environmental compliance and obsolescence management solutions in the form of data content, web-based tools, and hosted services. Total Parts Plus suite of products provide information and reporting on RoHS Compliance, REACH/SVHC, Conflict Minerals, etc… and electronic component obsolescence management to include PCN’s, alternate sourcing, alternate equivalents, and life cycle predictions. To learn more, visit home.totalpartsplus.com.

About ParkerGale: ParkerGale Capital is a private equity firm based in Chicago that invests in small, profitable software companies where the firm’s operating resources can have a meaningful impact on the outcome. ParkerGale also hosts the Private Equity FunCast available on iTunes, Google Play, and wherever you get your podcasts. To learn more, visit www.parkergale.com.

ECHA Updates SVHC Candidate List to 219 Substances

The European Chemicals Agency (ECHA) has added eight additional substances to the Candidate List of Substances of Very High Concern (SVHC), which brings the current total to 219 SVHCs as of July 8th, 2021. The new SVHCs were added to the candidate list based on their hazardous properties (toxic, carcinogenic, etc).

  • 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers
  • Orthoboric acid, sodium salt (CAS 13840-56-7)
  • 2,2-bis(bromomethyl)propane1,3-diol (BMP); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA); 2,3-dibromo-1-propanol (2,3-DBPA) (CAS 3296-90-0; 36483-57-5; 1522-92-5; 96-13-9)
  • Glutaral (CAS 111-30-8)
  • Medium-chain chlorinated paraffins (MCCP) UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
  • Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)
  • 1,4-dioxane (CAS 123-91-1)
  • 4,4′-(1-methylpropylidene)bisphenol (CAS 77-40-7)

The SVHC Candidate List is updated biannually with new substances being reviewed for addition on a continual basis. Suppliers of articles which contain an SVHC substance above a concentration of 0.1% w/w have a legal obligation to provide customers with enough information to allow safe usage of the article – at minimum, the name of the SVHC(s) present above the REACH threshold must be communicated.

Beginning January 2021, suppliers of articles within or into the European Union containing an SVHC above the 0.1% w/w threshold must provide information on their safe use to ECHA via the SCIP database.

TPP can help your company meet your REACH reporting goals using our compliance reporting services. You can find out more about SVHC candidate list updates, notification requirements, and ECHA’s SCIP database by reaching out to our sales team today via our Contact Us webform. Interested in our suite of online tools? Request a demonstration today.

Read ECHA’s official press release here for more information about the SVHC candidate list.

CMRT Version 6.1 Now Available

The latest version of the Conflict Minerals Reporting Template (CMRT) was released April 28, 2021 and is now available for download from the Responsible Minerals Initiative – RMI.

The CMRT is a free, standardized reporting template developed by the RMI which facilities the transfer of information through the supply chain regarding mineral country of origin and the smelters and refiners being utilized. The template also facilitates the identification of new smelters and refiners to potentially undergo an audit via the RMI’s Responsible Minerals Assurance Process (RMAP).

The major changes you will see in CMRT v. 6.1 include:

  • Corrections to all bugs and errors
  • Updates to the Smelter Reference List and Standard Smelter List
  • Translation improvements

The next version of the CMRT is anticipated to be released in spring 2022.

RMI has also released guidance notes in several languages in regards to Questions 3 and 4 pertaining to covered countries and Conflict-Affected and High-Risk Areas here.

Click here for a downloadable version of the most up-to-date Smelter Reference List and here for the revision history.  

Click here for a new downloadable guide on how to complete CMRT v. 6.0.

For more information on how Total Parts Plus can assist you with meeting your conflict minerals needs and completing your due diligence, please visit our website.     

Öko-Institut Publishes Final Report Regarding Potential Additions to Annex II of the RoHS Directive

The Öko-Institut has published their final report from Pack 15, which includes an assessment of potential impacts caused by restrictions on several substances (or groups of substances).

 

Not recommended for inclusion into Annex II of the RoHS Directive:

– Beryllium and its compounds

– Five cobalt salts

– Diantimony trioxide (ATO, flame retardant)

– Indium phosphide (InP)

– Nickel sulfate and nickel sulfamate

 

Recommended for inclusion into Annex II of the RoHS Directive:

– Medium chain chlorinated paraffins (MCCPs) – Alkanes, 14-17, chloro

– Tetrabromobisphenol A (TBBP-A, flame retardant)

 

Annex II of the RoHS directive was amended in 2015 and currently lists ten restricted substances, as well as their associated maximum concentration value by weight in homogenous materials. The maximum permitted concentration of all substances is 0.1% except cadmium, which is restricted at 0.01%. However, certain substances may be exempt from restriction when it is technically or scientifically impracticable to prohibit their usage.

 

Lead (Pb)

Mercury (Hg)

Cadmium (Cd)

Hexavalent chromium (Cr6+)

Polybrominated biphenyls (PBB)

Polybrominated diphenyl ether (PBDE)

Bis(2-ethylhexyl) phthalate (DEHP)

Butyl benzyl phthalate (BBP)

Dibutyl phthalate (DBP)

Diisobutyl phthalate (DIBP)

 

The RoHS Directive was created to reduce the environmental and health impacts of electronics by restricting specific hazardous materials and substances found in electrical and electronic equipment. Additional substances that are identified as potentially hazardous are evaluated against guidelines set in Article 6(1) of the RoHS Directive.

 

Total Parts Plus is the leading provider of parts data content for product environmental compliance and lifecycle management. Reach out to our sales team today to schedule a demonstration of our suite of software tools to help your company track RoHS, REACH, conflict minerals, and more!

 

https://home.totalpartsplus.com/

 

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Fort Walton Beach, FL

1-877-912-7278

ECHA Updates SVHC Candidate List to 211 Substances

The European Chemicals Agency (ECHA) has added two additional substances to the Candidate List of Substances of Very High Concern (SVHC), which brings the current total to 211 SVHCs as of January 19, 2021. Both substances are considered toxic for reproduction and may be found in products such as plastics, rubbers, and inks.

  • Bis(2-(2-methoxyethoxy)ethyl)ether (CAS # 143-24-8) – Used as a solvent and extraction agent.
  • Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety – Used as an additive in the production of plastics and rubber tires.

Suppliers of an article containing an SVHC above the concentration of 0.1% weight by weight have the legal obligation to provide, at minimum, the name of the SVHC(s) present to ensure safe usage of the article by customers and consumers.

Under the Waste Framework Directive, ECHA now additionally requires suppliers of articles within or into the European Union containing an SVHC above the 0.1% w/w threshold to provide safe use information regarding that substance through the SCIP database.

For more information regarding how TPP can assist in meeting your REACH reporting goals, contact our sales team today using our Contact Us webform.

The official ECHA press release can be read here for additional information.

Oeko-Institut Announces RoHS Exemption Renewal Request Project (Pack 22)

The Oeko-Institut has started a new RoHS project which will assess multiple RoHS exemption renewal requests. The assessment will involve a technical and scientific review on whether the renewal requests are justified based on Article 5(1)(a) of the RoHS Directive.

Article 5(1)(a) provides that materials and components may be exempted from the RoHS substance restrictions if this does not weaken the environmental and health protection of the RoHS Directive and any of the following conditions are fulfilled:

  • The elimination or substitution of the restricted substance is scientifically or technically impracticable.
  • The reliability of the substitutes is not ensured.
  • The total negative environmental, health, and consumer safety impacts caused by the substitution are likely to outweigh the total environmental, health, and consumer safety benefits.

The following Annex III RoHS exemptions will be reviewed:

  • 6(a) “Lead as an alloying element in steel for machining purposes and in galvanized steel containing up to 0.35 % lead by weight.”
  • 6(a)-I “Lead as an alloying element in steel for machining purposes containing up to 0.35 % lead by weight and in batch hot dip galvanized steel components containing up to 0.2 % lead by weight.”
  • 6(b) “Lead as an alloying element in aluminum containing up to 0.4 % lead by weight.”
  • 6(b)-I “Lead as an alloying element in aluminum containing up to 0.4 % lead by weight, provided it stems from lead-bearing aluminum scrap recycling.”
  • 6(b)-II “Lead as an alloying element in aluminum for machining purposes with a lead content up to 0.4 % by weight.”
  • 6(c) “Copper alloy containing up to 4 % lead by weight.”
  • 7(a) “Lead in high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead).”
  • 7(c)-I “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.”
  • 7(c)-II “Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher.”

The evaluation will be performed in cooperation with the European Commission as well as stakeholders and is scheduled to be concluded July 27, 2021 after which a final report will be published.

You can find out more about Oeko-Institut’s evaluation process by visiting their official website.

Total Parts Plus can help your company keep track of RoHS exemptions, including expiration dates and renewal requests. Reach out to our sales team today for a demonstration of our suite of environmental compliance programs. 

ECHA Updates SVHC Candidate List to 209 Substances

The European Chemicals Agency (ECHA) has added an additional four substances to the Candidate List of Substances of Very High Concern (SVHC), bringing the total number of SVHCs to 209 as of June 25th, 2020. The four new substances are added based on their reprotoxic and endocrine disrupting characteristics.

  • 1-vinylimidazole (CAS # 1072-63-5) – Used in formulations and as a monomer in the production of polymers.
  • 2-methylimidazole (CAS # 693-98-1) – Used as a catalyst in the production of coating products.
  • Dibutylbis(pentane-2,4-dionato-O,O’)tin (CAS # 22673-19-4) – Used as a catalyst and as an additive in the production of plastics.
  • Butyl 4-hydroxybenzoate (Butylparaben) (CAS # 94-26-8) – Used in cosmetics, personal care products, and pharmaceuticals.

The SVHC Candidate List is updated biannually with new substances being reviewed for addition on a continual basis. Suppliers of articles which contain an SVHC substance above a concentration of 0.1% w/w have a legal obligation to provide customers with enough information to allow safe usage of the article – at minimum, the name of the SVHC(s) present above the REACH threshold must be communicated.

Beginning January 2021, suppliers of articles within or into the European Union containing an SVHC above the 0.1% w/w threshold must provide information on their safe use to ECHA via the SCIP database.

TPP can help your company meet your REACH reporting goals using our compliance reporting services. You can find out more about SVHC candidate list updates, notification requirements, and ECHA’s SCIP database by reaching out to our sales team today via our Contact Us webform. Interested in our suite of online tools? Request a demonstration today.

Read ECHA’s official press release here for more information about the SVHC candidate list.

CMRT Version 6.0 Now Available

The latest version of the Conflict Minerals Reporting Template (CMRT) was released May 13, 2020 and is now available for download from Responsible Minerals Initiative – RMI.

The CMRT is a free, standardized reporting template developed by the RMI which facilities the transfer of information through the supply chain regarding mineral country of origin and the smelters and refiners being utilized. The template also facilitates the identification of new smelters and refiners to potentially undergo an audit via the RMI’s Responsible Minerals Assurance Process (RMAP).

The major changes you will see in CMRT v. 6.0 include:

  • Corrections to all bugs and errors
    • Update to ISO country, state and province lists
  • Conformance to IPC-1755, which incorporated EU Conflict Minerals Regulation in the wordings of the following questions: Q 4 (newly added), Q H (formerly Q I), removal of former question C
  • Updates to the Smelter Reference List and Standard Smelter List

The next version of the CMRT is anticipated to be released in spring 2021.

CMRT v. 6.0 Template  Download CMRT

  • Click here for a downloadable version of the most up-to-date Smelter Reference List and here for the revision history.

CMRT v. 6.0 Resources:

  • Click here for a new downloadable guide on how to complete CMRT v. 6.0. CHIJPN also available.

For more information on how Total Parts Plus can assist you with meeting your conflict minerals needs and completing your due diligence, visit our website.     

Eleven New Substances Added to REACH Annex XIV

The European Commission has announced the addition of eleven new substances to Annex XIV of the REACH Authorization List. These substances have been determined to be toxic, persistent, and/or bioaccumulative.

  • 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear (CAS # 68515-50-4) – Toxic for reproduction (category 1B)
  • Dihexyl phthalate (CAS # 84-75-3) – Toxic for reproduction (category 1B)
  • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0,3 % of dihexyl phthalate (CAS # 68515-51-5; 68648-93-1) – Toxic for reproduction (category 1B)
  • Trixylyl phosphate (CAS # 25155-23-1) – Toxic for reproduction (category 1B)
  • Sodium perborate; perboric acid, sodium salt – Toxic for reproduction (category 1B)
  • Sodium peroxometaborate (CAS # 7632-04-4) – Toxic for reproduction (category 1B)
  • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1- yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2- (4,6-dimethylcyclohex-3-en-1-yl)-5-methyl- 1,3-dioxane [2] [covering any of the individual stereoisomers of – vPvB
  • 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) – (CAS # 25973-55-1) – PBT, vPvB
  • 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2- yl)phenol (UV-327) – (CAS # 3864-99-1) – vPvB
  • 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6- (sec-butyl)phenol (UV-350) – (CAS # 36437-37-3) – vPvB
  • 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) – (CAS # 3846-71-7) – PBT, vPvB

Annex XIV of the REACH regulation (also called the REACH authorization list) contains substances which are subject to authorization. These substances are selected from the REACH SVHC candidate list and cannot be placed on the EU market after their sunset date unless the substance has been authorized for a specific use.

You can view the European Commission’s official publication regarding the additions here. TPP’s sales team is available to answer any questions your company may have regarding the REACH regulation. Visit our website to learn more about our suite of products that are available to suit your needs.