Source: Barbara Wert, Sr. Regulatory Compliance Specialist
RoHS – RECAST v. AMENDMENT
Contrary to what many believe, the updated requirement under 2015/863 for compliance to ten substances rather than six does not constitute the “next generation” of RoHS.
As of January 3, 2013, Directive 2002/95/EC (RoHS Directive), which had been in force since July 2006, was superseded by Directive 2011/65/EU (RoHS 2 Directive). This was known as the “RoHS Recast”.
To recast something is to give it a new form, or to redo it. Ultimately it is a complete replacement. Major enhancements contained in the RoHS Recast included:
• Alignment to other EU legislation, including product marking and declaration of conformity
• Identification of various economic operators and the obligations under each role
• Expansion of product scope
• Clarity on procedures for granting, renewing, and revoking exemptions
In contrast, an “amendment” does not give a new form to a document; it only incorporates minor changes for the purpose of improving the content.
In June 2016 Directive (EU) 2015/863 was implemented as an amendment to Annex II of Directive 2011/65/EU “Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials”. Article 4(1) itself did not change:
“Member States shall ensure that EEE placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, does not contain the substances listed in Annex II.”
Under (EU) 2015/863, ten substances are listed in Annex II:
• The original six substances – lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE)
• Four additional substances – bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP)
There are also clarifying statements as to the timeline imposed for the additional restrictions for articles such as medical devices, industrial monitoring and control instruments, and toys.
While many entities refer to the current regulation as “RoHS 3”, the restriction of hazardous substances is still legislated under RoHS 2 – Directive 2011/65/EU. Although updated declarations of compliance are not required (since the “parent” directive has not changed), it is suggested that RoHS references in declarations can be updated to “Directive 2011/65/EU as amended by (EU) 2015/863” to give clarity to the reader that the product has been evaluated to the current legislation.
REACH SVHC LIST IS NOW 201
As of July 16, the REACH Substances of Very High Concern (SVHC) list contains 201 substances. The four latest additions include:
• 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides
• 2-methoxyethyl acetate
• Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)
Guidance for communicating the presence of new SVHC in a product is found in the publication “Guidance on requirements for substances in articles” (June 2017). 1 This guidance states that the supplier of an article containing a substance has to provide to the recipient of the article or to a consumer relevant safety information” when both of the following conditions are met:
• The substance is included in the Candidate List for authorization, and
• The substance is present in articles produced and/or imported above a concentration of 0.1% (w/w)
The guidance further states that the information is to be provided to the recipient of the article (industrial or professional users and distributors) for the first time after the inclusion of the substance into the Candidate List, and to the consumer upon request by that consumer, within 45 days of that request and free of charge.
Knowing whether or not a substance (and how much of it) is contained in an article requires the article be evaluated to the substance. The best way for interested parties to be aware of what substances are being considered for inclusion on the SVHC list and have products evaluated in a timely manner is to monitor the “Registry of SVHC intentions until outcome” site and the Public activities coordination tool (PACT). ECHA sends out weekly and quarterly newsletters to keep interested parties informed about any future updates of the SVHC list.
UAE RoHS – ARE YOU READY FOR 1/1/20?
When UAE RoHS came into force, certain products were slated for implementation as of January 1, 2020. Those products include:
• Medical devices, and In vitro diagnostic medical devices
• Monitoring and control instruments, and Industrial monitoring and control instruments
• Products in category 11 (“Other EEE” not covered by categories 1-10)
A Certificate of Conformity issued by Emirates Authority for Standardization & Metrology is required for importation to the UAE.
EEU RoHS – ARE YOU READY FOR 3/1/20?
On March 1, 2020 the transitional period for coming into compliance with the Eurasian Economic Union technical regulation “On limiting the use of hazardous substances in electrical products and radio electronics (TR EAEU 037/2016)” comes to a close. Decision 167/2018 includes a listing of applicable HS codes, and requirements include a Declaration of Conformity to TR 037/2016 and affixing the EAC mark to the product.
NEW EU REGULATION 2019/1020
The regulation “on market surveillance and compliance of products” was adopted on June 20, 2019, to “complement and strengthen existing provision in Union harmonization legislation relating to the ensuring of compliance of products”.
A Union Product Compliance Network is being established to enhance coordination between enforcement authorities of the EU member states and the European Commission and streamline practices of market surveillance within the Union and will be in place by January 1, 2021.
The Directive also establishes the requirement that a product can only be put on the market in the European Union if there is an Economic Operator established in the Union. The Economic Operator can be any of the following:
• A manufacturer established in the Union
• An Importer, where the manufacturer is not established in the Union
• An Authorized Representative who has a written mandate from the manufacturer
The presence of an Economic Operator within the European Union is required as of July 16, 2021.
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