On November 15, 2018, the Emirates Authority For Standardization & Metrology issued an updated guidelines document confirming that the scope of UAE RoHS includes B2B (business to business) products. The guidance suggests that a simplified process for a certificate of conformity is being provided for B2B products; however, a very short interim period makes this process impractical except for products that were already lined up for certification through a Certification Body
Tag Archives: RoHS
EU – Scope Changes to the EU RoHS Directive
The European Commission has drafted an amendment to the EU RoHS Directive (2011/65/EU) updating the scope of the Directive to fix the various issues that have been identified since RoHS 2 was published in 2011. This includes the provision in the Directive that prevents used medical devices, control and monitoring instruments and other EEE that did comply with the substance restrictions from being resold after July 2019.
The amendment will make the following changes to the Directive:
- The July 2019 limitation on re-selling non-compliant re-used EEE (Article 2, paragraph 2) is deleted
- An exclusion is added for Pipe organs
- The definition of “non-road mobile machinery made available exclusively for professional use” is updated.
- The requirement for category 11 “other EEE” to comply with the substance restrictions starting on 22 July 2019 is added to the end of paragraph 3 of Article 4. The revised paragraph will read:
- 3. Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diagnostic medical devices which are placed on the market from 22 July 2016, to industrial monitoring and control instruments which are placed on the market from 22 July 2017 and to all other EEE that was outside the scope of Directive 2002/95/EC which is placed on the market from 22 July 2019.;
- Category 11 “other EEE” put on the EU market before 22 July 2019 was added to the list of product categories that may be repaired/refurbished with non-compliant spare parts and cables (i.e., repair as originally sold).
- For category 11 “other EEE”, the original Annex III exemptions are valid until 5 years from 22 July 2019
- The statement “The Commission shall decide on an application for renewal of an exemption no later than 6 months before the expiry date of the existing exemption unless specific circumstances justify other deadlines.” In Article 5(5) is deleted.
The amendment is not official until it is published in the Official Journal of the EU.
RoHS Amendment adding Phthalates to Restricted Substances is Published
The European Delegated Directive (EU) 2015/863 officially adding the four (4) Phthalate substances to the EU RoHS Directive was published today, June 4, 2015. The new phthalate restrictions take effect beginning July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments). Category 8 and 9 products have an additional 2 years and need to comply by July 22, 2021. EEE manufacturers and their suppliers now have just over four years to prepare.
The amendment adds the four phthalates shown below to Annex II (Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials) of the the RoHS Directive . A maximum concentration value of 0.1% w/w in homogeneous material was specified for the phthalates in the amendment.
Four Phthalate Substances to be Added to RoHS Directive
| Substance Name | CAS Number | Maximum Concentration in homogeneous material |
|---|---|---|
| Bis(2-ethylhexyl) phthalate (DEHP) | 117-81-7 | 0.1% |
| Benzyl butyl phthalate (BBP) | 85-68-7 | 0.1% |
| Dibutyl phthalate (DBP) | 84-74-2 | 0.1% |
| Diisobutyl phthalate (DIBP) | 84-69-5 | 0.1% |
Spare Parts and Cables
The official publication of the amendment was delayed by a few months to allow the European Commission time to add verbiage clarifying the implication on cables and spare parts. This new text aligns with the general RoHS intention to allow products to be repaired using the same parts that were used in the original product when if was first put on the EU market. The published amendment states:
The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.
Phthalates in Electrical/Electronic Toys
The amendment is also explicit that the phthalates in toys restriction in Annex XVII of the REACH regulation takes precedence over the maximum concentration levels in the RoHS Directive.
What’s the Impact? How to Proceed?
The four phthalates are already listed on the REACH SVHC Candidate List — this gives manufacturers that have REACH SVHC information from their suppliers a head start in assessing the parts and materials that require substitution. However, the different basis for calculating concentration level between REACH and RoHS (article vs. homogeneous material) will undoubtedly create some surprises.
In electrical and electronic equipment (EEE), DEHP is generally considered to be the most commonly used of the four phthalates. DBP and BBP also have known applications; whereas DIBP is considered to have minimal usage within the EEE supply chain.
The results of a study published in 2010 at the IPC APEX conference “Where are REACH SVHC in Electronic Products and Parts?” may provide some insight to the use and prevalence of these substances. The study investigated and compiled analytical test results for the initial batch of SVHCs added to the REACH Candidate List (including 3 of the phthalates just added to RoHS). The analytical testing was performed in Asia, North America, and Europe on EEE and materials typically used in EEE. DEHP was detected above the SVHC threshold (0.1% wt/wt in the article) in 64 of 391 testing results (16%). The study was focused on the REACH SVHC threshold which is based on articles. However, had the study considered a concentration threshold based on homogeneous material, the number of products above the threshold would likely have been much higher.
In the time since 2010, many manufacturers that have been trying to eliminate SVHCs from their product have removed the phthalates from external cables (where they are above 0.1% in the article); but DEHP may still be present in internal cables which are relatively small and for which the phthalate content did not trigger the 0.1% threshold based on imported article.
Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. The amendment to the RoHS Directive is posted on the Official Journal of the EU. ECD Compliance provides services to track environmental regulations and can assist in upgrading your RoHS program to address the phthalate restrictions.
RoHS Exemption 7(b) Renewal Request is Withdrawn
Renewal of EU RoHS exemption 7(b) “Lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signalling, transmission, and network management for telecommunications” has had very little support from large multi-national equipment manufacturers and is destined to quietly expire on July 21, 2016.
Quintech Electronics & Communications, Inc. submitted a renewal request for a modified 7(b) exemption with a reduced scope “Lead in solders for RF switching matrices and associated RF signal distribution equipment for telecommunications”, However, the consultants conducting the review notified stakeholders on April 9th, 2015 that the renewal request was withdrawn by the applicant.
There are no remaining renewal requests for exemption 7(b) and therefore, the exemption, which has been a mainstay of the communications, telecommunication, and server equipment industries since 2006, will disappear next July. Once expired, it will not longer be possible for manfucturers, importers and distributers to claim the exemption for products being placed on the EU market except for spare parts to repair old products.
EU – Update on RoHS Exemption Renewals
The European Commission received 87 RoHS Annex III exemption renewal requests before the January 21, 2015 deadline. Most of the renewal requests were based on proposals developed by industry association working groups. The exemptions will expire on July 21, 2016 for most products unless the renewal applications are successful. For some exemptions, multiple renewal requests were submitted by different stakeholders. The requests will be put through the review and stakeholder consultation over the coming months to determine whether the renewals are justified according to the criteria specified in the Directive.
For most of the renewal requests, the proposal is to simply renew the existing wording of the exemption; for a few exemptions, modified wording is proposed. The Annex III exemptions that are due for expiry and have no exemption renewal request (as of January 21, 2015) are listed in Table 2.
Table 2: Exemptions with no renewal request by January 21, 2015
| Index | Title |
|---|---|
| 2(b)(2) | Mercury in other fluorescent lamps not exceeding (per lamp):Non-linear halophosphate lamps (all diameters): 15 mg |
| 5(a) | Lead in glass of cathode ray tubes |
| 17 | Lead halide as radiant agent in high intensity discharge (HID) lamps used for professional reprography applications |
| 25 | Lead oxide in surface conduction electron emitter displays (SED) used in structural elements, notably in the seal frit and frit ring |
| 30 | Cadmium alloys as electrical/mechanical solder joints to electrical conductors located directly on the voice coil in transducers used in high-powered loudspeakers with sound pressure levels of 100 dB (A) and more |
| 31 | Lead in soldering materials in mercury free flat fluorescent lamps (which e.g. are used for liquid crystal displays, design or industrial lighting) |
| 33 | Lead in solders for the soldering of thin copper wires of 100 micrometer diameter and less in power transformers |
| 38 | Cadmium and cadmium oxide in thick film pastes used on aluminium bonded beryllium oxide |
Four renewal requests received by the Commission are already underway and the public consultation is scheduled to begin in March. A summary of the renewal requests and the project is available on the project website. The project (referred to as Pack 7) is expected to complete in September 2015.
Impact on Manufacturers
If the renewal of an Annex III exemption that you are currently using is not successful or if the scope of the exemption is narrowed whereby your products/applications are no longer covered, the expiry may have a significant technical and business impact on your organization. If the expired exemption was used by your suppliers, the suppliers may need to design out the restricted substance. However, given the R&D investment to do so, some suppliers may discontinue parts that do not have sufficient business justification. If parts are discontinued, then OEMs will need to identify and qualify substitutes.
If the restricted substance is directly specified by your organization (for example in a material specified on a mechanical drawing or during manufacturing operations); then redesign will be necessary to eliminate the restricted substance.
Regardless of whether the exemption is used by a supplier or in your product design specifications, your organization will need to update its RoHS technical documentation file to demonstrate that the exemption is no longer being used.
Updates
The renewal request for exemption 7(b) was withdrawn on April 9, 2015. See blog article RoHS Exemption 7(b) Renewal Request is Withdrawn
RoHS Exemptions Published in Official Journal of the EU – April 10, 2015
Two new EU RoHS exemptions were published in the Official Journal of the European Union on Friday, April 10, 2015. Both exemptions are added to Annex IV of the Directive which is applicable to category 8 “Medical devices” and category 9 “Monitoring and control instruments including industrial monitoring and control instruments”.
Commission Delegated Directive (EU) 2015/573 officially adds exemption 41 to Annex IV:
41. Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases. Expires on 31 December 2018.
Commission Delegated Directive (EU) 2015/574 officially adds exemption 42 to Annex IV::
42. Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation. Expires on 30 June 2019.
Both these exemptions have been under development and review for several years — the first public consultation occuring in 2013.
Contact ECD Compliance to learn how regular updates on regulatory changes and standards and their impact to your products/markets can improve efficiency and reduce business risk.
RoHS 2 Phthalates Restriction Clarified for Spare Parts and Cables
The European Commission has clarified the impact of the upcoming RoHS 2 Phthalates restrictions on spare parts and cables for products that were put on the EU market before the new substance restrictions come into effect. The clarification was made March 13, 2015 in response to comments the EC had received to their WTO notification of the draft amendment adding the four phthalate substances to Annex II of the RoHS Directive (2011/65/EU).
The Commission proposed the following draft recommendation to be included in the ANNEX II amendment:
“The restriction of DEHP, BBP and DBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the EEE of ANNEX I categories 1-7, 10 and 11 that is placed on the market before 22 July 2019, and the EEE of ANNEX I categories 8 and 9 that is placed on the market before 22 July 2021.”
ECD Compliance is providing services to assist manufacturers with implementing the phthalates restrictions in supply chain management and manufacturing operations efficiently and cost effectively.
New Substances for RoHS Directive Notified to WTO
The European Commission moved forward with its update of the List of Restricted Substances in the RoHS Directive, Annex II. The Commission has notified the World Trade Organization that the four phthalate substances will be added to the RoHS substance restrictions. The restrictions take effect beginning in July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments) which will have an additional 2 years and need to comply by July 22, 2021. This provides most EEE manufacturers and the global supply chain with four and a half years to prepare.
Four Phthalate Substances to be Added to RoHS Directive
| Substance Name | CAS Number | Maximum Concentration in homogeneous material |
|---|---|---|
| Bis(2-ethylhexyl) phthalate (DEHP) | 117-81-7 | 0.1% |
| Benzyl butyl phthalate (BBP) | 85-68-7 | 0.1% |
| Dibutyl phthalate (DBP) | 84-74-2 | 0.1% |
| Diisobutyl phthalate (DIBP) | 84-69-5 | 0.1% |
The maximum concentration value for the phthalates will be 0.1% w/w in homogeneous material.
The four phthalates are already listed on the REACH SVHC Candidate List — this gives manufacturers that have REACH SVHC information from their suppliers a head start in assessing the parts and materials that require substitution. However, the different basis for calculating concentration level between REACH and RoHS (article vs. homogeneous material) will undoubtedly create some surprises.
Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. ECD Compliance provides services to assess your product requirements for compliance to environmental regulations and to implement compliance procedures.
The notified Directive is available on the WTO website.