ECHA launched a public consultation on the restriction proposal for Perfluorohexanoic acid (PFHxA), its salts and related substances in the EU. PFHxA substances are used in the manufacture of fluoropolymers (plastics which may be used in EEE) and clothing. They are used as manufacturing chemicals and typically would not remain in a finished product; however, the proposed threshold for PFHxA substances in polymers is very low (0.0001%) meaning that even residual amounts of the substances could be above the restriction level.
PFHxA substances are also used in semiconductor manufacturing operations. An exemption is proposed for this application.
Additional information on the proposed restriction and the consultation may be found on the ECHA website.
 PFHxA consultation website, https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/25419/term
The May 18, 2020, the EU officially updated the reference standard for EU RoHS technical documentation to IEC EN 63000 from the previous standard EN 50581. The change was published in EU Decision (EU) 2020/659. EN 50581 remains valid until November 18, 2021.
Impact on EEE Manufacturers
The transition to IEC 63000 has been planned for the past couple years and should not have a material impact on conformity assessment– both IEC 63000 and EN 50581 specify very similar requirements.
Manufacturers with products that are in scope of EU RoHS should start to update their EU Declarations of Conformity to reference IEC EN 63000 (or IEC 63000) instead of EN 50581. An 18-month transition period is provided to make the changes.
ECD Compliance has launched services to help manufacturers, suppliers, and solution providers understand and meet the emerging requirements for the European Substances of Concern in Products (SCIP) database.
SCIP submissions pose new challenges for manufacturers, importers, and distributors while enforcement becomes easier — the EU authorities know which type of products typically contain SVHCs and they will be able to check the online database to see if the substances have been properly reported. Manufacturers need to collect additional information from suppliers, interpret and compile the data into the format specified by ECHA, and then submit into the online SCIP database.
ECD Compliance will keep your organization up to date on regulatory developments and on emerging industry practices for SCIP. The service may be scaled up to support supplier engagement, data collection processes and SCIP data compilation.
Under REACH Article 33, manufacturers are already required to provide SVHC information to customers in the EU. The new SCIP reporting obligations require duty holders to submit this and other information about the product and the first article containing the SVHC into the database. This information includes tariff codes, article identifiers, material category, concentration information, EU production, etc. This raises several concerns including protection of confidential business information (CBI).
Contact ECD Compliance for more information on the SCIP services.
Eurasian RoHS takes effect starting March 1, 2020. The substance restrictions and conformity requirements will be in effect across the Eurasian Economic Union (EAEU) which includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. The substance restrictions and thresholds are the same six substances that were initially restricted in EU RoHS. The main difference with Eurasian RoHS is the submission of certification and/or declaration documentation.
The Eurasian RoHS technical regulation was published as TR EAEU 037/2016 on restricting the use of hazardous substances in electrical engineering and radio electronic products. It applies to a broad range of EEE products. In October 2018, a specific list of products (with custom codes) was published as EAEC Decision No. 167 to supplement the original regulation. Continue reading
In a November 18, 2019 press release, ECHA announced the results and publication of the official report on a REACH Article 33 Enforcement Project involving 15 EU countries. The project tested 682 articles from 405 companies; products included: “clothing, footwear and home textiles; wires, cables and electronic accessories; plastic or textile floorings; wall coverings; and other plastic and rubber products”
Of the articles tested, 12% (84 of 682) were found to contain at least one Candidate List Substance above 0.1%.
- For 45 of those, there was a duty to communicate SVHC information down the supply chain (b2b) as per REACH Article 33; however, the communication requirement was met for only 5 of the articles resulting in an 89% non-compliance.
- For companies supplying articles directly to consumers (b2c), 22 of 43 suppliers were considered as not providing enough information about the SVHCs to ensure safe use.
The overall verdict made by ECHA in the report is that the level of REACH SVHC in articles disclosure is not acceptable and steps need to be taken to improve the situation.
ECHA pointed to the upcoming SCIP database as one tool that should help start to drive improvements in SVHC disclosure.
The ECHA press release and report are available on the ECHA website.
 ECHA press release, https://echa.europa.eu/-/companies-need-to-improve-communication-of-hazardous-substances-in-products
On November 12, 2019, ECHA hosted a workshop in Helsinki on the upcoming SCIP database. The workshop included several presentations from ECHA including an overview of the database, reporting requirements, data format, and protection of CBI, an industry presentation on global supply chains, a presentation on the view from waste operations, and an NGO presentation on use cases for the presentation. Several challenging questions and use cases were raised that ECHA said they will need to investigate. These included reporting challenges associated with multiple sources of suppliers parts and what happens when a product has multiple configurations that impact the number of articles with SVHCs.
The European Chemical Agency (ECHA), on January 16, 2020 added four additional substances and substance groups to the EU REACH Candidate List. The new Substance of Very High Concern (SVHC) entries are listed in the table below. There is now a total of 205 SVHCs on the REACH Candidate List. The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE – two of the four SVHCs are possible EEE constituents. The IEC 62474 DSL was also updated on January 16, 2020.
|Substance name||EC||CAS||Examples of use(s) (ECHA)
|Diisohexyl phthalate||276-090-2 ||71850-09-4||Not registered under REACH.
|2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone||404-360-3||119313-12-1||The substance is used in polymer production
|2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one||400-600-6||71868-10-5||The substance is used in polymer production
|Perfluorobutane sulfonic acid (PFBS) and its salts ||-||-||Used as a catalyst/ additive/reactant in polymer manufacture and in chemical synthesis. It is also used as a flame retardant in polycarbonate (for electronic equipment).
The IEC 62474 International Material Declaration standard was revised in 2018 as part of a periodic review. The revised International Standard was published in November 2018, introducing several new capabilities based on emerging regulatory requirements, user feedback, and the needs of other industries. This included a new Declaration for Compliance module and additional support for EU REACH compliance and the upcoming EU Substance of Concern in Products (SCIP) database. The changes were also intended to make the standard more useful to industries other than the electrotechnical products. This had been requested by National Committees who intended to use the standard across a broad range of industries from the chemicals through all downstream manufacturers
Adoption of IEC 62474 as European and National Standards
IEC 62474 has been adopted as the European standard for material declaration (EN 62474). It’s also been adopted as National Standards by several other countries including Japan, China, and Brazil.
Support for Supplier Declaration for EU SCIP Database Continue reading
On October 31, 2019, ECHA published the data format that manufacturers, importers, and distributors will need to follow to submit data into the Substances of Concern in Products (SCIP) database. ECHA is currently developing a prototype system that it expects to have available for public testing in late January next year. The fully functional system for duty holders to start submitting information is expected to be ready in October 2020. The legal obligation to have submitted SVHC information starts in just over a year on January 5, 2021.
ECHA is providing three methods for duty holders to submit their article and substance information:
- Online submission via a web-based user interface;
- Offline using the ECHA IUCLID tool and then submitting manually;
- System to system – a company’s own IT system creates all of the submissions according to the IUCLID data format and then uses a system-to-system portal to submit multiple records into the system.
The same information needs to be provided regardless of which submission method is used. The system-to-system will be most efficient for large organizations with many products containing SVHCs and by solution providers who can afford the custom IT development. The cloud-based approach will be well suited for organizations that need to make only a few submissions and don’t wish to undertake the training needed to use the IUCLID tool.
The ARTICLE XML schema published by ECHA gives us a good indication of the data needed for submission. The schema bundles the information into data groups (see Figure 2) for: Identifiers, Categorization, Characteristics, Safe Use Instructions, Complex Object Components, and Concern Elements. The Concern Element contains information about the SVHC in the article and the type of material/mixture that the SVHC is contained in.
Figure 2: Structure of Article into data groups
ECHA also revealed that several of the data fields will use picklists provided by ECHA. This means that an exact entry from the list will need to be submitted instead of free text. Data fields using picklists include:
- Primary article identifier (Type) (e.g. EAN, GPC, GTIN, with option for other)
- Other article identifier (Type) (e.g. EAN, GPC, GTIN, with option for other)
- other names (Type) (e.g. brand, model, type with option to specify other)
- Article categories (i.e. CN codes)
- Produced in European Union
- Unit of measure for characteristics
- Candidate List Version
- Concentration range
- Material category
- Additional material characteristics
- Mixture category
- Language of disassembly instructions
There is also a data field to indicate that the Candidate List Substance is no longer present within the article.
The ARTICLE XML schema is included as part of the latest release of the ECHA IUCLID data format (IUCLID 6.4) and is available on the ECHA website. ECHA updates the IUCLID format once a year.
On October 1, 2019, the European Chemical agency (ECHA) submitted it’s ninth recommendation to the European Commission for substances to be added to the REACH Annex XIV Authorisation List. This recommendation includes 18 substances that are currently on the REACH Candidate List of SVHCs (Table 1).
When a substance is added the Authorisation List it’s given a sunset date. Once the sunset date has passed, no one in the EU may manufacture or use the substance unless they’ve been granted an authorisation to do so.
Table 1: SVHCs recommended for REACH Annex XIV
|Name||EC Number||CAS Number||Recommendation year
|4,4'-isopropylidenediphenol (bisphenol A; BPA)||201-245-8||May 7, 1980||9 (draft: September 2018; final: October 2019)
|1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[126.96.36.199,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”™) covering any of its individual anti- and syn-isomers or any combination thereof||9 (draft: September 2018; final: October 2019)
|Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-HPbl)||9 (draft: September 2018; final: October 2019)
|2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)||239-622-4||15571-58-1||9 (draft: September 2018; final: October 2019)
|Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)||9 (draft: September 2018; final: October 2019)
|4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)||209-218-2||561-41-1||9 (draft: September 2018; final: October 2019)
|Dioxobis(stearato)trilead||235-702-8||12578-12-0||9 (draft: September 2018; final: October 2019)
|Fatty acids, C16-18, lead salts||292-966-7||91031-62-8||9 (draft: September 2018; final: October 2019)
|Trilead dioxide phosphonate||235-252-2||12141-20-7||9 (draft: September 2018; final: October 2019)
|Sulfurous acid, lead salt, dibasic||263-467-1||62229-08-7||9 (draft: September 2018; final: October 2019)
|[Phthalato(2-)]dioxotrilead||273-688-5||69011-06-9||9 (draft: September 2018; final: October 2019)
|Trilead bis(carbonate) dihydroxide||215-290-6||1319-46-6||9 (draft: September 2018; final: October 2019)
|Lead oxide sulfate||234-853-7||12036-76-9||9 (draft: September 2018; final: October 2019)
|Cyclohexane-1,2-dicarboxylic anhydride , cis-cyclohexane-1,2-dicarboxylic anhydride , trans-cyclohexane-1,2-dicarboxylic anhydride  [The individual cis-  and trans-  isomer substances and all possible combinations of the cis- and trans-isomers  are covered by this entry]||201-604-9"236-086-3"238-009-9||85-42-7"13149-00-3"14166-21-3||9 (draft: September 2018; final: October 2019)
|Hexahydromethylphthalic anhydride , Hexahydro-4-methylphthalic anhydride , Hexahydro-1-methylphthalic anhydride , Hexahydro-3-methylphthalic anhydride  [The individual isomers ,  and  (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers  are covered by this entry]||247-094-1"243-072-0"256-356-4"260-566-1||25550-51-0"19438-60-9"48122-14-1"57110-29-9||9 (draft: September 2018; final: October 2019)
|Tetraethyllead||201-075-4||78-00-2||9 (draft: September 2018; final: October 2019)
|2-methoxyethanol||203-713-7||109-86-4||9 (draft: September 2018; final: October 2019)
|2-ethoxyethanol||203-804-1||110-80-5||9 (draft: September 2018; final: October 2019)
There are currently 43 substance entries on the REACH Annex XIV Authorisation List with an additional 58 entries recommended but not yet implemented (including the most recent 18 submissions).