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meet the criteria for classification as dangerous according to Regulation (EC) No 1272/2008 which replaced the fully repealed Directive 67/548/EEC and Directive 1999/45/EC.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.

Advertisements

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

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.

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.

United Arab Emirates RoHS

On April 28. 2017, the United Arab Emirates (UAE) version of RoHS took effect. The UAE version of RoHS is based upon EU RoHS and also adopts a very rigorous timeline with data submissions due to Emirates Authority for Standardisation and Metrology (ESMA) as early as January 1, 2018, depending on product category.

To declare under the UAE Directive, “Form A” is stipulated as the template for the UAE RoHS COC. “Form A” does not exist under UAE RoHS, but rather is an indication of “Module A” from 768/2008/EC, a product marketing decision by the European Commission. A description of “Module A” may be found here, beginning on page 17:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF

ESMA, the agency tasked with collection and enforcement of UAE RoHS, is using a certification system (ECAS) by which companies would register products and issue a declaration of conformity. In return, any company (or its authorized representative) making a declaration would receive a “conformity acknowledgement” to retain for 10 years. To use ECAS, a company would register and then issue the declarations via the system. However, at the time of this article, there is no current way to use the system to declare UAE RoHS. There are fees associated with ESMA registration and product/DOC evaluation. Please see the ESMA site here: http://www.esma.gov.ae/en-us/Services/Pages/ECAS.aspx

Additionally, the UAE’s version of the RoHS directive calls for annual renewal of the DOC.

The current consensus is that any existing (acceptable) EU RoHS DOC is going to be acceptable for UAE RoHS. This is due to the harmonization between UAE and EU RoHS. However, this harmonization has its own issues as UAE is not a member state of the EU, likely would never be a member state of the EU, and is relying upon a foreign directive that has grown and changed in scope, exemptions, details, and substances. Hence, there may be issues that confront UAE RoHS in the future.

Finally, any additional questions regarding ECAS registration, product declaration, and UAE RoHS may be directed to customercare@esma.gov.ae, the contact for ESMA.

Ukraine’s Version of RoHS Now in Force

On September 22, 2017, Ukraine’s version of RoHS entered into force as the Ukrainian Technical Regulation on the restriction of hazardous substances in electrical and electronic equipment.

Adopted to align with the existing EU RoHS, manufacturers importing electrical and electronic equipment (EEE) to Ukraine are compelled to certify compliance with Ukraine’s RoHS Technical Regulation. There is a grace period for medical devices and controlling & monitoring instruments which will be held to the regulation as of January 1, 2018.

Manufacturers must also retain records of non-compliant EEE, and product recall details. EEE must now be properly marked, and are required to alert Ukrainian governmental agencies if any EEE placed on the market does not meet the RoHS requirements. This notification may result in further actions to remedy the non-compliant items on the market.

From the perspective of impact, manufacturers may expect to see requests from customers and importers selling products on the Ukraine market. These requests will encompass a declaration of conformity (DOC) in the format indicated by Annex V of the regulation.

As with EU RoHS, the substances are the same (Lead, Cadmium, Mercury, Hexavalent Chromium, PBB, and PBDE). There is also a planned ‘phase-in’ for the restriction of phthalates. DEHP and BBP are restricted in certain applications, such as in toys, by January 1, 2018. DEHP, BBP, DBP, and DIBP are restricted excepting categories 8 & 9 by July 22, 2019, and are restricted in all EEE by July 22, 2021.
As new material content directives emerge and evolve, it is very important to have the ability to determine product compliance in a real-time environment. With access to the latest compliance information from your suppliers, a direct communication link to your suppliers, and real-time reporting tools Green Data Exchange can provide the solutions you need to maintain compliance and report to your customers, auditors, and regulatory agents.
Please continue to check the Q Point Technology Blog for recent news on material compliance regulations and other important news on compliance.

Singapore Adopts RoHS

Singapore’s 2002 Environmental Protection and Management Act has been amended to include Restrictions of Hazardous Substances. The amendment was initially proposed over a year ago by Singapore’s National Environment Agency (NEA).

The restrictions affect electrical and electronic equipment (EEE) as specified by the amendment. The hazardous substances and threshold for compliance reflect the same substances and thresholds in EU RoHS. For reference, the substances are:

  • Cadmium – 0.01%
  • Hexavalent Chromium – 0.1%
  • Lead – 0.1%
  • Mercury – 0.1%
  • Polybrominated biphenyls (PBB) – 0.1%
  • Polybrominated diphenyl ethers (PBDE) – 0.1%

Similarly, NEA has adopted all of the EU RoHS Substance Application Exemptions.

Current scope of the amendment is limited to 6 categories of EEE (mobile phones, mobile computers, refrigerators, air conditioners, panel TVs and washing machines). These 6 EEE are restricted to finished EEE that are meant for local sale to consumers. EEE designed solely for specialized/industrialized uses are excluded under the control.

The amendment as Singapore RoHS enters into force on June 1, 2017.

Environmental regulation, including RoHS, REACH and Conflict Minerals, continues to expand in scope and breadth, both covering new substances, thresholds and requirements, but also new and emerging markets.

Green Data Exchange can help you meet your compliance obligations. Learn more by visiting our website at www.qpointtech.com.