Product Compliance –  2018

Product Compliance –  2018

The European Union (EU) REACH Regulation updates in 2017 included a lot of new substances. The Environmental Protection Agency also started to implement several amendments to the Toxic Substances Control Act of the United States.

There are series of regulatory changes that are expected to occur in 2018. In-scope companies will be expected to meet latest requirements throughout several product compliance regulations, with REACH Regulation and RoHS Directive not left out.

Below is a list that highlights the developments that will be vital in compliance, as predicted by some of our reliable experts.

 

Proposition 65 Labeling Requirements

On the 30th of August, 2016, Proposition 65 – Article 6 of the California Safe Drinking Water and Toxic Enforcement Act – was amended. The amendment helped in clarifying the warning label requirements. It is expected that new requirements will be effected on 30th of August, 2018. When it does, labels and signage must include:

  • Name of one or more Proposition 65-listed substance
  • Pictogram for enhanced visibility
  • Short or long form warning.

Suppliers are advised to personalize warnings to their respective industries. Companies are expected to comply with the newly amended rules, if not, they will face a fine of $2,500 daily, including further legal actions.

 

 

RoHS Phthalate Elimination

Furthermore, there are additional restrictions on four phthalates that are anticipated to be effected on the 22nd of July, 2019. The substances include:

  • Benzyl butyl phthalate (BBP)
  • Bis(2-ethylhexyl) phthalate (DEHP)
  • Dibutyl phthalate (DBP)
  • Diisobutyl phthalate (DIBP)

 

Companies that currently sell or supply products that contain any of the substances listed about in the EU are expected to fact fast so as to meet these latest requirements.

 

New UAE RoHS Restrictions Come Into Effect

As of the 1st of January, 2018, new restrictions will come into effect for substances and chemicals that are being sold or supplied in (UAE). The substances include:

  • Lead (Pb)
  • Cadmium (Cd)
  • Mercury (Hg)
  • Polybrominated diphenyl ether (PBDE)
  • Polybrominated biphenyls (PBB)
  • Hexavalent chromium (Cr6+)

Any company that is yet to sort out their obligations under the regulation should kindly do so in 2018. As the restrictions have been forcefully implemented, companies need to start looking forward to the next UAE RoHS deadline.

 

REACH Candidate List Updates

On 15th of January, 2018, seven news substances were added to the REACH Candidate List by ECHA. They include:

  • Chrysene
  • Cadmium nitrate
  • Benz(a)anthracene
  • Cadmium carbonate
  • Cadmium hydroxide
  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde, and 4-heptylphenol, branched and linear (RP-HP) (with ≥0.1% w/w 4-heptylphenol, branched and linear)
  • 1,6,7,8,9,14,15,16,17,17,18,18- Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”TM) (covering any of its individual anti- and syn-isomers, or any combination thereof)
  • Bisphenol A has also been updated to contain its environmental endocrine-disrupting properties. Companies are expected to start gathering necessary information about these substances.

 

REACH Registration Deadline

Lastly, the 31st of May, 2018 will mark the final deadline for REACH registration. Any substance or chemical imported into the EU after that day, at more than a ton per annum, must be registered with the ECHA.

 

To know more about how our TPP team can help your get in touch with us today. Our team will be available to provide answers to all of your questions.

European Commission Environment Director : Update

The European Commission Environment Director has issued another update. This is aimed at Annex III depending on the various field of application, so as to extend their validity.

These drafts will give the Member States up two twelve months to make necessary amendments. Once the period elapsed without any form of approval, the directives will have no option than to force their way into adopting and publishing the revisions. Once they force their way, it is expected that the revision will come into force the following day.

During this period, suppliers and manufacturers will have to review compliance documentation so as to show the newly revised exemptions.

In addition, it is expected that this batch will include action on Annex III exemptions 7(c)-II, 7(c)-IV, 8(b), 15, 21, 29, 32 and 37. The comment period will open until the 15th of March.

– Below is the full list. It has been summarized, with links to comment and actual drafts pages appropriately included.

Although, it is important to note that the expiration dates will start in July 2021. Companies can apply for renewal 18 months prior to the expiration date. Thus, you only have less than two years to process applications for replacement or renewal technologies.

A new study to “reform the current approach which is used to identify and assess substances for likely constraints under RoHS 2” and evaluate seven substances for potential addition:

tetrabromobisphenol-A (TBBPA)
diantimony trioxide
Medium Chain Chlorinated Paraffins (MCCPs) indium phosphide
nickel sulphate and nickel sulfamate beryllium and its compounds
cobalt dichloride and cobalt sulphate

The majority of these substances are widely used. Click here to visit the website of the Commission on this “2018 Review”. Check out TPP’s website to stay informed about the status of important topics such as these.

SGS: EU Publishes on RoHS 2

SGS: EU Publishes on RoHS 2

The RoHS 2 Directive (EU) 2017/2102 has been issued by the EU. This will help provide more information as regards the scope of application as well as the exemption validity period. The directive was issued on the 21st of November, 2017 to help amend 2011/65/EU on RoHS 2.

On 1st of July, 2011, 2011/65/EU (RoHS 2) was published by EU’s official journal. This helped in expanding the scope of the product to the various categories of electrical and electronic equipment (EEE). In addition, the restricted list of substances was also amended, adding four more phthalates by Directive (EU) 2015/863. This was later published on the 4th of June, 2015.

 

According to:

  1. The RoHS 2 scope now excludes pipe organs.
  2. The definition of ‘non-road mobile machinery which were previously made available exclusively for professional use’ has also been amended.
  3. The RoHS 2 scope now encompass all electrical and electronic equipment placed on the market before 22nd of July 2019, although they were excluded from the scope of Directive 2002/95/EC.
  4. Furthermore, all other electrical and electronic equipment which were outside the Directive 2002/95/EC scope and which is placed on the market before 22nd of July 2019 is newly added to paragraph 4, Article 4 of 2011/65/EU.
  5. In the event that reuse takes place in auditable closed-loop business-to-business return systems, and that customers are not notified about spare parts reuse, paragraph 1 will not apply to reused spare parts:

 

  1. Recovered from electrical and electronic equipment which are placed on the market before 1st of July, 2006 and used in electrical and electronic equipment placed on the market before 1st of July, 2016.
  2. Recovered from control and monitoring instruments or medical devices that are put on the market before 22nd of July, 2014 and used in electrical and electronic equipment put on the market before 22nd of July, 2024.
  3. Recovered from in vitro diagnostic medical devices put on the market before the 22nd of July, 2016 and used in electrical and electronic equipment placed on the market before 22nd of July, 2026.
  4. Recovered from industrial monitoring and control instruments placed on the market before 22nd of July, 2017 and used in electrical and electronic equipment put on the market before 22nd of July, 2027.

 

  1. Finally, it is now possible to renew the maximum validity of the exemptions that are listed in Annex III.

Seven Substances Proposed for Authorization by ECHA

As a way of ensuring the quality of materials used for production, ECHA has proposed seven additional SVHCs be added to the REACH Authorization List.

These seven substances have been made a priority from the Candidate List due to their fundamental properties. As the substances are used extensively, this extensive use can constitute a threat to both the human health and the environment at large.

While some of these substances are not presently in use in the EU, they are likely to be used as replacements for other endorsed substances or those already on the Authorisation List. These substances have been recommended for authorisation to escape regrettable substitution.

The seven substances are included in the 8th recommendation of ECHA to the European Commission to prioritise substances that possess profound concern. Five of the substances have very persistent and very bioaccumulative (vPvB) and/or persistent, bioaccumulative and toxic (PBT) properties. The other two are considered toxic and should not be used due to reproduction hazards.

A public consultation on the draft recommendation was organised by ECHA between March and June 2017. The Member State Committee (MSC) reflected on the received comments and found reasons for the recommendations. The recommendation was later adopted on the 11th of December 2017.

ECHA noted the comments and registration updates, including the opinion of the Member State Committee when determining the substances. These substances were later recommended to be included in the REACH Authorisation List (Annex XIV) and to suggest the latest application and sunset dates. Each substance that went through public consultations has been added to the final recommendation.

As of now, the European Commission has yet to make its final decision on including the substances in the Authorization List. The European Commission still needs to consult the Member States and the European Parliament before a final decision is made. Once this is done, the dates for application for authorization to ECHA by companies will then be released.

Seven new substances added to the Candidate List, entry for bisphenol-A updated

Latest REACH Regulation Updates – TPP

As the New Year unfolds, a lot of changes are being anticipated by the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation. Member State Committee of ECHA has come to an agreement to include seven new substances to the already existing Candidate List of the substances of very high concern (SVHC). In addition to that, the entry for Bisphenol A. will also be updated.

However, as a result of the legal obligations related to this recent development, companies inside the scope of the regulation will be required to take immediate action.

 

Seven New SVHCs

The recent development and announcement show the unending commitment of ECHA to ensure that the various requirements of REACH are regularly updated using the understanding of the dangerous effects of the chemicals used in manufacturing consumable products to both our health and the environmental. The following are the seven substances which have been recognized to be included on the Candidate List of SVHCs:

  • Chrysene
  • Dechlorane plus™
  • Cadmium nitrate
  • Benz[a]anthracene
  • Cadmium carbonate
  • Cadmium hydroxide
  • Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde, and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear]

 

Updates to Bisphenol A

The ECHA has also decided to agree with the proposal made by Germany for Bisphenol A (BPA) to be identified as an SVHC. However, the intrinsic properties of BPA are already recognized as “toxic for reproduction.” With “endocrine disrupting properties for human health”, the revision includes its potential for “endocrine disrupting properties in the environment.”

Several companies will be affected by this latest update. Plans are in place for the legal obligations to start once the Candidate List has officially been updated this January.

 

 

 

Get Ready to Respond

Furthermore, it is important for you to stay up-to-date and remain aware of any latest development. It is important that you maintain a healthy communication link between you and your suppliers. This will help determine whether any of the substances just regulated recently are contained in your products above the 0.1% article benchmark.

In the event that any product turns out to be non-compliant, it becomes an obligation for you to notify the ECHA if they are being imported into the EU by your company at a rate of above a ton per year.

 

Get in Touch With Us Today!

We have what it takes to assist you in responding to any product compliance requirement as fast as possible. Our regulatory team will make use of our up-to-date REACH Module to provide you with the opportunity of launching data collection campaigns as fast as possible. Thus, making it possible for you to check products for new, latest SVHCs.

New Version of the Conflict Minerals Reporting Template Version (CMRT) Released

New Version of the Conflict Minerals Reporting Template Version (CMRT) Released

The new version of the Conflict Minerals Reporting Template version (CMRT) has been released. The 5.10 CMRT was released on December 1, 2017 by Responsible Minerals Initiative (RMI).

The 5.10 CMRT is an update from the 5.01 CMRT released in June 2017.

Changes and updates to Conflict Minerals Reporting Template version 5.10 include:

  • Correction to bugs and errors (debugging).
  • Enhancements that do not conflict with IPC-1755.
  • Updates to the smelter reference list and standard smelter list.
  • Change to .xlsx format.

 

The rebranding of the Conflict- Free Sourcing Initiative, (CFSI) to the Responsible Minerals Initiative, (RMI).

Formally known as the Conflict-Free sourcing initiative, (CFSI) was rebranded to what it now is, the Responsible Minerals Initiative, (RMI). RMI identifies and verifies smelters and refiners, provides guidance in due diligence frameworks, and maintains the CMRT. The CMRT is updated twice a year.

CLICK HERE TO: DOWNLOAD CMRT TEMPLATE

Total Parts Plus offers a conflict minerals tool to streamline data collection and analysis of CMRTs from your supply chain to help meet Dodd-Frank requirements. As well as conflict minerals management, Total Parts Plus offers RoHS, REACH and full material declaration management of your bill of materials. For more information on the data collection and management services of Total Parts Plus, please visit: www.totalpartsplus.com or call 850.244.7293.

Registration Statistics deadline 2018*

REACH 2018

Update to REACH 2018 statistics – 12 000 registrations submitted for the last deadline

The statistics about the registrations for the May 2018 deadline have been updated. 12 131 registrations have been submitted for 5 596 substances. The biggest number of registrations were recorded from Germany, the United Kingdom and France.

Registration statistics 2018 | Overall registrations

 

CLICK HERE:    reach_2018_result_stats_en

TPP to Implement CMM 4.1 Enhancement |  Conflict Minerals Reporting


 

TPP to Implement CMM 4.1 Enhancement

 Conflict Minerals Reporting

 

TPP is enhancing the CMM 4.1 application with the addition of the CMRT Module for Conflict Minerals reporting.

The CMRT Module gives users access to supplier CMRT and Conflict Minerals statements as well as all relevant Supplier and Smelter information, and supply chain response status.

The CMRT roll-up aggregates all supplier answers and smelter data to satisfy customer Conflict Minerals Reporting requirements, and the reporting features allow easy identification of 3TG presence, gap analysis, and smelter issues.

Companies can identify smelters which are CFSP certified by RMI (previously CFSI), smelters which have been removed from the known smelter list and smelters that have known issues.  The data will allow users to perform due diligence and assess the risk in their supply chain, which is vital in completing the Form SD and meeting the requirements of Dodd-Frank Conflict Minerals legislation.

Please contact us to learn more about how TPP and the CMM 4.1 CMRT Module can ease the burden of Conflict Minerals reporting for the 2017 reporting period.

 

The updates will go into effect

November 22, 2017

PROPOSITION 65 & 3 NEW SUBSTANCES

If уоu’rе a Cаlifоrniа rеѕidеnt оr уоu’vе purchased supplements from Cаlifоrniа, by nоw уоu’vе рrоbаblу ѕееn the Prор 65 wаrning lаbеl that’s рlасеd оn thousands of рrоduсtѕ.

 

Thеѕе labels аrе infаmоuѕ fоr their ѕеvеrе wаrningѕ and it’ѕ only nоrmаl tо bе соnсеrnеd whеn you ѕее ѕuсh wаrningѕ on a label. Hоwеvеr, thе рrоduсtѕ fоrсеd to uѕе thеѕе lаbеlѕ аlrеаdу mееt оr еxсееd сurrеnt regulations to bе sold lеgаllу.

 

Thiѕ lеаdѕ tо the ԛuеѕtiоn уоu are probably аѕking — if thе warnings оn thе Prор 65 lаbеlѕ аrе truе, hоw аrе thеѕе рrоduсtѕ still on thе mаrkеt?

 

Aѕ with mаnу California rеgulаtiоnѕ, it’ѕ hаrd tо find a straightforward еxрlаnаtiоn. Hоwеvеr, we’re gоing tо dо our bеѕt tо brеаk dоwn Prор 65 fоr уоu аnd lеt уоu drаw уоur оwn conclusion.

 

Whаt is Prop 65?

 

In 1986, еnvirоnmеntаl and рubliс hеаlth асtiviѕtѕ persuaded California vоtеrѕ tо approve thе Sаfе Drinking Water аnd Tоxiс Enforcement Aсt — more commonly known аѕ Proposition 65 оr Prop 65.

 

Although the intentions bеhind Prop 65 wеrе to imрrоvе рubliс hеаlth, vеrу littlе imрrоvеmеnt hаѕ асtuаllу resulted. It’ѕ questionable whether оr not thе burdеn рlасеd on California buѕinеѕѕеѕ hаѕ bееn wоrth it.

 

Prор 65 rеԛuirеѕ:

 

Thе State of California tо idеntifу chemicals thаt соuld роtеntiаllу саuѕе саnсеr, birth defects, or rерrоduсtivе hаrm. Eасh nеw chemical diѕсоvеrеd is added tо a liѕt mаnаgеd bу the ѕtаtе. The list tоtаl iѕ over 800 сhеmiсаlѕ аnd соunting.

 

Buѕinеѕѕеѕ to wаrn consumers оf аnу роѕѕiblе еxроѕurе tо one of thе сhеmiсаlѕ оn the liѕt, dеѕрitе thе асtuаl аmоunt оf ingrеdiеnt or rеаliѕtiс riѕk of еxроѕurе. Tо ассоmрliѕh thiѕ, buѕinеѕѕеѕ аrе rеԛuirеd to post in-ѕtоrе ѕignѕ аnd/оr wаrning lаbеlѕ оn specific рrоduсtѕ.

 

Whаt ingrеdiеntѕ аrе inсludеd in Prор 65?

 

Currently, thеrе are оvеr 800 сhеmiсаlѕ idеntifiеd by the Stаtе of California аѕ саrсinоgеnѕ аnd rерrоduсtivе tоxinѕ that rеԛuirе thе Prор 65 warning. But recently, they just added the following to the list of the chemicals. All three of the newly added substances were determined by OEHHA to cause cancer.

The three substances are:

 

  • N,N-Dimethylformamide (CAS No. 68-12-2)
  • 2‑Mercaptobenzothiazole (CAS No. 149-30-4)
  • Tetrabromobisphenol A (TBBPA) (CAS No. 79-94-7)

 

Thе Prор 65 liѕt соntаinѕ a broad rаngе оf nаturаllу оссurring аnd ѕуnthеtiс сhеmiсаlѕ thаt аrе known by thе ѕtаtе оf Cаlifоrniа to саuѕе саnсеr оr birth dеfесtѕ оr other rерrоduсtivе hаrm.

 

Hоwеvеr, Prop 65 requires a warning lаbеl оn аnу рrоduсt соntаining a ѕinglе сhеmiсаl from thеir list.

Prop 65 ѕеtѕ a “Sаfе Hаrbоr” еxроѕurе lеvеl for a lоt оf thе listed chemicals аnd аmоuntѕ lеѕѕ thаn thе Sаfе Hаrbоr lеvеl rеԛuirе nо wаrning lаbеl. Yеt, Sаfе Harbor lеvеlѕ аrе frеԛuеntlу аrоund 1,000 times lower than levels ѕеt bу the FDA, EPA аnd WHO.

 

In fact, the Sаfе Hаrbоr lеvеlѕ are ѕо lоw fоr mаnу common сhеmiсаlѕ thаt they’re virtuаllу imроѕѕiblе to nоt ѕurраѕѕ. In mоѕt inѕtаnсеѕ, thе еxроѕurе lеvеlѕ dеtеrminеd bу Prop 65 аrе lower thаn what оссurѕ nаturаllу in fruitѕ, vеgеtаblеѕ, grаinѕ, аnd even drinking wаtеr.

Update on REACH Annex XVII Restricted Substances?

In the bid of REACH to ensure that only safe and healthy substances are circulated on the European market, a recent list was released to the Annex XVII. Below are the recent update on the substances restricted by REACH in the Annex XVII as of 30 August 2017, containing the list of substances, mixtures, and articles that are considered hazardous to be used or marketed on the European market.

  1. Entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006 forbids selling, marketing, using or supplying to the general public with substances that are now regarded as mutagenic, carcinogenic, or reproductive toxicant (CMR). Mixtures that contains certain quantity of these substances have also been prohibited.

 

  1. The Part 3 of Annex VI now contains substances that have been classified as CMR in line with Regulation (EC) No 1272/2008 of the European Parliament and of the Council.

 

  1. Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006 have been updated to reflect new classifications of substances as CMR under Regulation (EC), while the Part 3 of Annex VI to the latter has been modified by Commission Regulations (EU).

 

  1. Furthermore, operators still have the opportunity of applying the harmonised classifications listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008. Provision of this regulation can be applied earlier voluntarily.

 

  1. The association has also gone on to amend Regulation (EC) No 1907/2006

 

  1. Various measures put in place for in this Regulation are in line with the Committee’s opinion established under Article 133 of Regulation (EC) No 1907/2006,

 

The above amendment of the Annex XVII to Regulation (EC) No 1907/2006 is in accordance with the Annex. The regulation is likely to enter into force by the twentieth day of the release of this publication. The banned substances are mentioned below

bisphenol A; [phenol, dodecyl-, branched]; [phenol, 2-dodecyl-, branched]; [phenol, 3-dodecyl-, branched]; [phenol, 4-dodecyl-, branched]; [phenol, (tetrapropenyl) derivatives]; chlorophacinone (ISO); coumatetralyl (ISO); difenacoum (ISO); flocoumafen (ISO); disodium octaborate anhydrous; disodium octaborate tetrahydrate; bromadiolone (ISO); difethialone; [perfluorononan-1-oic acid, and its sodium and ammonium salts]; dicyclohexyl phthalate and triflumizole (ISO).

More update on the banned substances here