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.

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.

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!

 

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Fort Walton Beach, FL

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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.

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.

TPP Verified as an IPC-1752A Solution Provider

TPP is pleased to announce that we have again been verified as a solution provider of IPC-1752A Classes A, C, and D including the multi-layered structure in Class D.

The IPC-1752A standard is extensively used in the electronics industry for the transfer of compliance information throughout the supply chain for electrical and electronic products. This standard establishes a reporting format for data exchange between all supply chain participants and is XML-schema based. The standard is regularly updated and maintained by industry experts in order to meet changing requirements, legislation, and regulation.

In order to be verified, a solution provider must submit example XML files reporting IPC-1752A Class A, C, and/or D in either request/reply and/or distribute mode. Upon inspection by the review committee, the file may receive comment and be verified based on the following criteria:

  • File(s) must comply with IPC-1752A XML file format.
  • File(s) must use IPC-1752A lists of regulated substances and exemption correctly.

TPP provides a free IPC-1752 generator tool, as well as a paid version which includes additional features not available in the free tool.

Free IPC-1752A Generator

Have questions about the IPC-175x family of standards? Reach out to our sales team today to find out more about the suite of compliancy tools available at TPP.

Want to find out more about the solution provider review process? Visit the Materials Declaration Data Exchange Standards page for an explanation of each standard.

TPP to attend IPC Apex Expo 2020

TPP will again be attending this year’s IPC Apex Expo taking place February 1st through February 6th at the San Diego Convention Center. The expo, which is the largest event for electronics manufacturing in North America, is the industry’s leading technical conference.

 

TPP’s director of environmental engineering, Ms. Nikki Johnson, is a member of several committees working on the IPC-175x family of standards. This family establishes a standard reporting format for data exchange between supply chain participants. This series of standards is XML-schema based, which allows for more efficient and effective communication of data.

 

Ms. Johnson also chairs the E-31H “Responsible Sourcing of Minerals Data Exchange Standard” committee, which will be celebrating the approval of the 1755B standard that has been updated to include EU conflict minerals requirements.

 

You can find out more about the expo at the official IPC Apex Expo 2020 website.

 

Interested in learning more about the IPC-175x family of standards and how the decisions of the committee’s may affect your products? Reach out to our sales team by visiting the TPP website for more information.

TPP to Exhibit at DMSMS 2019

Total Parts Plus is pleased to announce that we will be exhibiting at the DMSMS symposium scheduled for December 2-5, 2019 in Phoenix, Arizona.

The Diminishing Manufacturing Sources and Material Shortages (DMSMS) event is an annual event that focuses on the identifying and mitigating supply issues resulting from obsolescence, loss of manufacturing sources, and material shortages that may result before the end of a product’s life cycle. The event is aimed at helping industries plan for sustainable systems in an accelerated acquisition environment.

TPP will be available to showcase our latest obsolescence and compliance management solutions. We help provide an all-inclusive solution for obsolescence tracking, compliance reporting, and data analysis.

Join TPP at Booth #241 and stay up-to-date on the latest industry trends, and learn new and exciting ways to sustain and grow your business. We hope to see you there!

You can find out more about obsolescence management by contacting one of our sales representatives today for a demonstration.

Visit the DMSMS event website for more information about the symposium.

ECHA Releases Requirements for Upcoming SCIP Database

Article 9 of the Waste Framework Directive requires suppliers of articles which contain an SVHC above the REACH threshold of 0.1% w/w to provide, at a minimum, the name of the SVHC(s) present per Article 33 of the REACH Regulation.

 

On September 9th, 2019 the European Chemicals Agency (ECHA) released a guide regarding the requirements for the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database. This database is designed to facilitate the collection and public availability of SVHC information for use by waste operators, consumers, NGOs, etc.

 

Companies which supply articles containing SVHC(s) above the threshold (EU producers and assemblers, EU importers, and EU distributors) will be required to provide sufficient information to allow safe usage of articles to ECHA, from January 5th, 2021. Some of the mandatory information to be submitted to the SCIP database will include:

 

  1. The identification of the article.
  2. The identification of the SVHC present.
  3. Information regarding the safe use of the article, if necessary.

 

The SCIP database will have three main objectives:

 

  1. Decrease the generation of waste containing SVHC(s) by supporting SVHC substitution.
  2. Make available information to improve waste treatment operations.
  3. Allow authorities to monitor SVHC(s), including their lifecycle and waste stages.

 

A conceptual model and additional information on the database is available at the ECHA website.

 

SCIP database will improve transparency on hazardous substances in articles

 

Additionally, ECHA has commissioned a team to collect feedback via an informal, stakeholder survey from both potential duty holders as well as potential users of the database. This survey will be used as a targeted consultation in order to further develop material categories and safe-use instructions, as well as assist in the standardization and dissemination of information via the SCIP database. You can access the Stakeholder Survey Questionnaire by following the link below.

 

Stakeholder Survey Questionnaire

 

Contact a TPP sales representative to find out more about how TPP can help you meet your compliancy goals for SVHC declaration, Article XVII information, and REACH regulatory requirements.

 

TPP – Total Parts Plus

RoHS, REACH, Conflict Minerals, Prop 65, and Obsolescence

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