ECHA Plans Database on Articles Containing Candidate List Substances

On July 11, 2018, ECHA announced plans for a new database for declaration of information related to articles containing Candidate List Substances. Declarations would be submitted by companies “producing, importing, or selling articles that contain Candidate List substances.”

For use by waste operators and consumers, this new database is being established in accordance with recent updates to 2008/98/EC, the Waste Framework Directive. Changes to the Waste Framework Directive passed on May 22, 2018 and set new targets for reuse and recycling of municipal waste. The database should “help waste operators in treating waste and recycling materials.”

Intention of the database is to help inform consumers to make safer choices, driving safe substitutes to market and “improve the risk management of chemicals during waste recovery” and “promote non-toxic material cycles.”

Current plans indicate the creation of the database by the end of 2019 with companies submitting data by the end of 2020. Note that if you are already using Q Point’s Green Data Exchange, you are already collecting the data and information that you would need to declare information on the use of SVHC in your articles.

Q Point will continue to follow developments on the new database and will post updates to this blog. For companies looking to collect data on Candidate List substances and usage within their own supply chain, please see our website for more details on Q Point’s solution, Green Data Exchange. For more information on the database, please see ECHA’s press release here or information on the Waste Framework Directive here.

Advertisements

Lead in Glass and REACH 191

ECHA has added lead (CAS No.: 7439-92-1) to the REACH Candidate List of substances, as of 27 June 2018. However, the way in which lead is used in your products may exempt it from the notification requirement of REACH, particularly if the lead is used in an application of a glass or ceramic frit. This article examines RoHS exemption 7(c)-I, currently renewed through 21 July 2021, REACH Annex V and its guidance from November 2012, as well as recent statements and positions from glass and ceramic manufacturers.

RoHS exemption 7(c)-I states the application of lead in the following is exempted.

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.

Based upon this exemption, any manufacturer using lead in this application would cite the exemption 7(c)-I on an EU RoHS Declaration of Conformity. However, the application of lead in this scenario would not require notification to customers on the use of lead as an SVHC for REACH. To understand why this is the case, let’s look at REACH Annex V.

Annex V of the REACH Directive lists thirteen categories of substances for which registration of the substance with ECHA is not necessary. There are, however, conditions to be met in order to claim the exemption. Criteria for meeting the conditions vary by category. Per the guidance on Annex V, published in 2012, but cited by ECHA as recently as May 2018, the criteria for glass and ceramic frit is that it must not meet the criteria for classification as dangerous according to Regulation (EC) No 1272/2008 which replaced the fully repealed Directive 67/548/EEC and Directive 1999/45/EC.

The rationale for the exemption is based upon the characterization of glass as an UVCB substance (unknown or variable composition, complex reaction products or biological materials). The guidance also suggests that glass “can best be defined through its starting materials and production process” for the purposes of legislation. Furthermore, the raw materials used in manufacturing a particular glass “meet the definition of intermediates inasmuch as they are transformed by synthesis into…glass.” This is based upon EU Court case-law found here. To this end, any glass or ceramic frit that does not possess significant hazard properties is exempted from REACH substance registration, thus precluding it from evaluation and further actions under REACH including notification of its use in articles.

Recent positions reiterating the exemption of glass have been stated by glass manufacturers and their associations. Glass Alliance Europe has published information detailing this position as well as many citations supporting the position of no notification on the use of lead for 7(c)-I exempted use of lead. Per Glass Alliance Europe there is “no obligation to notify under Art. 7(2) of REACH, nor to communicate information down the supply chain under Art. 33 of REACH. This was confirmed in ECHA Q&A – ID 1218 – 12/09/2016 relating to boron compounds.” Further, a prominent glass supplier in Germany states that as their “products consist mainly of glass and glass, as a substance, is not included in the Candidate List, there are no information duties under [REACH].”

To stay up to date with ever-changing regulations, obtain the data you need, and communicate in a real-time environment with your suppliers and customers for compliance information, please consider Green Data Exchange. To learn more, visit the Q Point Technology website and follow our corporate blog for the latest in news relative to material content compliance.

New Substances Considered for RoHS – RoHS Pack 15

The addition of seven new substances to the RoHS Annex II restricted substance list is being considered. Per article 6 of 2011/65/EU, restricted substances are to be periodically reviewed and Annex II is to be amended based upon “a thorough assessment.” Most frequently, this annex was updated to include 4 phthalates which will be enforced beginning in July 2019.

The “Study on the review of the list of restricted substances and to assess new exemption request under RoHS 2 – Pack 15,” conducted by Öko Institut & Fraunhofer Institute, sets out to update methodology for the “thorough assessment” of new restricted substances and then perform the assessment on the seven substances considered for inclusion.

The seven substances being considered are:

As an additional task to the assessment of the above substances, an evaluation of potential exemptions is being conducted.

 

To follow along with the project and to see relevant project documentation, please see http://rohs.exemptions.oeko.info/

 

As new substances are added to regulations, customers will need to determine their impact, both internally and upon the supply chain. Some stakeholders may begin inquiring about the presence and use of these substances within their supply chain immediately. In order to handle requests on emerging hazardous substances, you should be able to quickly request substance use information and check against existing data in a real-time environment. Green Data Exchange (GDX) will help you to respond to these requests today. By addressing any customer’s concerns over the use of emerging hazardous substances with fast and accurate responses, you can improve your own supplier performance score and obtain a competitive advantage over other suppliers.

 

In a review of recent history and new substance inclusion, Q Point notes that the process to include the 4 phthalates (the most recent change to RoHS) in Annex II began in 2012 and was not completed until June 2015, with an enforcement date of July 21, 2019. At this point, it is very likely that the Pack 15 substances are, at least, a couple of years away from enforcement. As new information is released, this blog will post relevant information and updates.

 

To learn more about solutions for material content restrictions, such as RoHS, please check out Green Data Exchange, GDX, at www.qpointtech.com

REACH SVHC UPDATE – REACH 191

On June 27, 2018, ECHA added ten new substances of very high concern (SVHC) to the REACH candidate list. The SVHC list is now at 191 substances. The new SVHC and common usage is found in the table below.

SVHC CAS No. Reason for Inclusion Common Usage
Benzene-1,2,4-tricarboxylic acid 1,2 anhydride

trimellitic anhydride; TMA

552-30-7 Respiratory sensitizing properties A reactive chemical compound used in the esterification of alcohols.

 

Benzo[ghi]perylene

 

191-24-2 PBT

vPvB

 

Research substance used to make dyes, plastics, pesticides, explosives, pharmaceuticals, bile acids, cholesterols, and steroids.

 

Decamethylcyclopentasiloxane

D5

541-02-6 PBT

vPvB

 

Emollient used in cosmetics, including sunscreen and hair care products.

 

Dicyclohexyl phthalate

DCHP

 

84-61-7 Toxic for reproduction

 

Endocrine disrupting properties

 

Substance used for manufacturing adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, finger paints, non-metal-surface treatment products, inks and toners, polishes and waxes, polymers and textile treatment products and dyes.

 

Disodium octaborate

 

12008-41-2 Toxic for reproduction

 

Insecticide
Dodecamethylcyclohexasiloxane

D6

540-97-6 PBT

vPvB

 

Substance used in washing & cleaning products, polishes and waxes, cosmetics and personal care products and pharmaceuticals.

 

Ethylenediamine

EDA

 

107-15-3 Respiratory sensitizing properties A substance used in the manufacture of fuel additives, bleach activators, chelating agents and corrosion inhibitors

 

Lead

 

7439-92-1 Toxic for reproduction Used in metal, especially copper alloys and stainless steels. Commonly found in paints, construction materials, flooring, leather products, and electrical & electronic equipment.

 

Octamethylcyclotetrasiloxane

D4

556-67-2 PBT

vPvB

 

Found in cosmetics and personal care products, washing & cleaning products and polishes and waxes.

 

Terphenyl, hydrogenated

 

61788-32-7 vPvB Heat transfer medium, can also be used as a plasticizer.

 

As REACH continues to update and evolve, it is very important to have the ability to determine individual component compliance in a real-time environment with access to the latest compliance information from your suppliers. Of similar importance is the ability to have a direct communication link to the contacts at your suppliers who author and provide the compliance data that you need. Green Data Exchange provides this today.

Please continue to check the Q Point Technology Blog for recent news on regulatory changes, including REACH updates.

 

RoHS Exemption Renewals

Per the European Journal, published on May 18, several exemptions for the use of lead in electrical and electronic equipment have been renewed.

The renewals, made via Commission Delegated Directives (2018/736 and following), extend the exemptions as currently constituted until 2021 with delayed expiration for products under categories 8 & 9 (in vitro diagnostic devices & industrial monitoring and control instruments, respectively).

The exemptions now extended are:

6(a) Lead as an alloying element in steel for machining purposes and in galvanized steel containing up to 0.35 % lead by weight. Expires on: 21 July 2021 for categories 8 and 9; 21 July 2023 for category 8 in vitro diagnostic medical devices; 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

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. Expires on 21 July 2021 for categories 1-7 and 10.

6(b) Lead as an alloying element in aluminum containing up to 0.4 % lead by weight. Expires on: 21 July 2021 for categories 8 and 9; 21 July 2023 for category 8 in vitro diagnostic medical devices; 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

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. Expires on 21 July 2021 for categories 1-7 and 10.

6(b)-II Lead as an alloying element in aluminum for machining purposes with a lead content up to 0.4 % by weight. Expires on 18 May 2021 for categories 1-7 and 10.

6(c) Copper alloy containing up to 4 % lead by weight. Expires on: 21 July 2021 for categories 1-10; 21 July 2023 for category 8 in vitro diagnostic medical devices; 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

7(a) Lead in high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead). Expires on: 21 July 2021 for categories 1-10; 21 July 2023 for category 8 in vitro diagnostic medical devices; 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

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. Expires on: 21 July 2021 for categories 1-10; 21 July 2023 for category 8 in vitro diagnostic medical devices; 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

24 Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors. Expires on: 21 July 2021 for categories 1-10; 21 July 2023 for category 8 in vitro diagnostic medical devices; 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

34 Lead in cermet-based trimmer potentiometer elements. Expires on: 21 July 2021 for categories 1-10; 21 July 2023 for category 8 in vitro diagnostic medical devices; 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

As RoHS continues to update and evolve, it is important to determine compliance of an individual component in a real-time environment. With access to the latest compliance information from your suppliers, Green Data Exchange provides real-time compliance information. GDX users have the ability to streamline supplier management efforts, review material content and regulatory compliance across suppliers and products, and automatically generate reports. Learn more www.qpointtech.com

For continued updates on RoHS exemption renewals and revisions, please be sure to follow the Q Point Technology Blog.

RMI’s Cobalt Reporting Template: A Pilot

The Responsible Minerals Initiative, RMI, has launched a pilot program to gather information on global cobalt supply chains. This pilot runs from March 1 until August 31, 2018.

Cobalt is expected to see a rise in demand due to its applications in battery technologies for mobile phones, laptops, and electric/hybrid vehicles.

The Democratic Republic of Congo, DRC, is the world’s leading producer of cobalt. Via the Conflict Minerals Act, tin, tantalum, tungsten, and gold from DRC have been tracked via the RMI’s Conflict Minerals Reporting Template (CMRT). While cobalt mining is not cited as being a source for conflict in the region, there have been reports of unsafe mining practices and the use of child labor.

Based upon the cobalt pilot, your company may ask or be asked by customers about the use of cobalt and cobalt sourcing practices. To learn more about the questions please find the RMI’s cobalt reporting template (CRT) at http://www.responsiblemineralsinitiative.org/emerging-risks/cobalt-reporting-template/

After the pilot period, there will be a feedback period from September 1 to October 1, 2018 where users may submit feedback via survey to the RMI. Results of the pilot will be reviewed by RMI with a decision on the continuation of the CRT by December 2018.

Using GDX to Get Ahead of RoHS 2 + Phthalates

In June of 2015, four phthalates were added to Annex II of the RoHS Directive. The European Commission selected an enforcement date of July 22, 2019 (2021 for Categories 8 & 9). Electrical and electronic equipment containing the phthalates will not be placed on the market in EU after the enforcement date. For more details on the added substances and the enforcement dates see this link.

Because of the additional substances, it is important to update and gather new RoHS compliance documentation at the “RoHS 2 + phthalates” level in order to maintain compliance and access to the EU markets. Green Data Exchange (GDX) has informed suppliers and educated in-house compliance teams about the needed updates to the RoHS Directive. Many suppliers have already updated their RoHS declarations in GDX to account for phthalates and are adding more data daily. In using GDX, you are able to ensure your compliance to RoHS 2 + phthalates well ahead of the enforcement dates.

On the term “RoHS 2 + Phthalates”

Q Point has adopted the title of “RoHS 2 + phthalates” when referring to the RoHS (recast) Directive 2011/65/EU + Directive 2015/863 which amends Annex II to include the four phthalates.

Some organizations have referred to the amended version of RoHS containing phthalates as “RoHS 3.” We maintain this is a misnomer as the RoHS Directive coming into force in 2019 maintains 2011/65/EU. The only distinction is the amended Annex II of 2011/65/EU which was done by the passing of ED 2015/863.

If you have any questions on RoHS 2 + phthalates, would like to learn about GDX, or to request a demo, please visit our website or email us at gdx_support@qpointtech.com.