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

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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.

China RoHS 2: What’s the Impact?

“Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products,” also known as China’s RoHS 2 regulation, was released on January 21, 2016 by China’s Ministry of Industry and Information Technology (MIIT).

Those involved in the manufacture of “in-scope” electrical and electronic products in China, import into China, and those sourcing from Chinese manufacturers should note the requirements of the new regulation.

Similar to EU RoHS, the regulation establishes a framework for content limits of the hazardous substances indicated. Cadmium, hexavalent chromium, lead, mercury, polybrominated biphenyls, and polyborminated diphenyl ethers must be within the content limits. The mechanism for content limits is a notable change and was not present in the previous China RoHS regulation.

Furthermore, China’s RoHS 2 regulation also stipulates requirements for labeling and the disclosure of information regarding product, part, component, and hazardous substance content. While there is already existing labeling and information disclosure requirements, the introduction of content limits will most likely result in a change to the current requirements.

There are further changes between RoHS 1 and RoHS 2. One major change is the expanded scope of electrical and electronic products. Per the regulation (Article 3(1))…

“Devices and accessory products with rated working electrical voltages of no more than 1500 volts direct current and 1000 volts alternating current which function by means of current or electromagnetic fields, and generate, transmit and measure such currents and electromagnetic fields.”

However, power generation, transmission, and distribution equipment are excluded.

Compulsory certification from RoHS 1 is now replaced by a conformity assessment system. Implementation of this system is ongoing and the requirements as yet are unclear. However, it is important to note that it is being developed among MIIT, the Certification and Accreditation Administration (CNCA), with input from other governmental agencies.

Also in RoHS 2, a “Compliance Management Catalogue” is being developed by MIIT. This will cover “in scope” products that may be deemed to require additional controls for a product’s end of life and hazardous substance content/use. The catalogue will be phased in over the course of the regulation.

RoHS 2 also establishes packaging requirements. The conformity to packaging material standards is now within the enforcement of China RoHS 2 and their agencies.

The China RoHS 2 Regulation has been developed over the course of ten years. This careful development results in a version of China RoHS that is more similar to EU RoHS than its preceding version. Replacement of the compulsory certification program suggests a regulatory atmosphere that will, at least tolerate – if not foster, development and innovation of products. MIIT will continue to update via FAQs and other documents.

For a full, translated version of the regulation, please see https://www.manufacturingindustryadvisor.com/wp-content/uploads/sites/11/2016/01/China-RoHS-2-Regulation-Final-Foley-Format-ENG-clean2.pdf