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EU – REACH Article 33 Enforcement Project Report

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[1].

[1] ECHA press release, https://echa.europa.eu/-/companies-need-to-improve-communication-of-hazardous-substances-in-products

EU – ECHA Hosts SCIP Workshop

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.

EU SCIP Database Support in IEC 62474

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

EU – ECHA Publishes Data Format for SCIP Database

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:

    1. Online submission via a web-based user interface;
    2. Offline using the ECHA IUCLID tool and then submitting manually;
    3. 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.

EU – ECHA Proposes 18 Substances for REACH Authorisation List

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

NameEC NumberCAS NumberRecommendation year
4,4'-isopropylidenediphenol (bisphenol A; BPA)201-245-8May 7, 19809 (draft: September 2018; final: October 2019)
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”™) covering any of its individual anti- and syn-isomers or any combination thereof9 (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)239-622-415571-58-19 (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)209-218-2561-41-19 (draft: September 2018; final: October 2019)
Dioxobis(stearato)trilead235-702-812578-12-09 (draft: September 2018; final: October 2019)
Fatty acids, C16-18, lead salts292-966-791031-62-89 (draft: September 2018; final: October 2019)
Trilead dioxide phosphonate235-252-212141-20-79 (draft: September 2018; final: October 2019)
Sulfurous acid, lead salt, dibasic263-467-162229-08-79 (draft: September 2018; final: October 2019)
[Phthalato(2-)]dioxotrilead273-688-569011-06-99 (draft: September 2018; final: October 2019)
Trilead bis(carbonate) dihydroxide215-290-61319-46-69 (draft: September 2018; final: October 2019)
Lead oxide sulfate234-853-712036-76-99 (draft: September 2018; final: October 2019)
Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] [The individual cis- [2] and trans- [3] isomer substances and all possible combinations of the cis- and trans-isomers [1] are covered by this entry]201-604-9"236-086-3"238-009-985-42-7"13149-00-3"14166-21-39 (draft: September 2018; final: October 2019)
Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] [The individual isomers [2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry]247-094-1"243-072-0"256-356-4"260-566-125550-51-0"19438-60-9"48122-14-1"57110-29-99 (draft: September 2018; final: October 2019)
Tetraethyllead201-075-478-00-29 (draft: September 2018; final: October 2019)
2-methoxyethanol203-713-7109-86-49 (draft: September 2018; final: October 2019)
2-ethoxyethanol203-804-1110-80-59 (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).

China — RoHS 2 Conformity Assessment in Effect

The China RoHS 2 conformity assessment requirements came into effect on November 1, 2019.  Manufacturers and importers of EEE products that are in the batch 1 product list had to either (1) complete voluntary certification with an accredited certification lab or (2) complete necessary registration and document submission for self-declaration.

China RoHS 2 Batch 1 Products

The batch 1 products that are in scope of the substance restrictions and conformity assessment obligations include: Refrigerator, Air conditioner, Washing machine, Electric water heater, Printer, Copier, Fax machine, TV set, Monitor, Microcomputer, Mobile phone, and Telephone.

China RoHS 2 Self-Declaration

For the self-declaration path, the manufacturer (or importer) registers on a centralized government system known as the “China RoHS Public Service Platform”.  The manufacturer then submits a completed self-declaration form and technical documentation demonstrating conformance to the substance requirements. There were several unknowns as to exactly how the system would operate and what documents had to be submitted, but that become clearer once the platform went live in early October. The China RoHS Public Service Platform is accessible at http://chinarohs.miit.gov.cn

During a recent presentation on the self-declaration approach, two types of documentation were discussed: (1) a Product Test Report or (2) Suppliers Conformity Report based on hazardous substance assessment of assemblies, parts and components.  This second approach is like European self-declaration using EN 50581/ IEC 63000. In fact, China adopted the IEC 63000 standard on restricted substance technical documentation as a China National standard (GB/T 36560-2018) for this purpose.

The completed self-declaration form needs to be submitted in simplified Chinese.

Figure 3: China RoHS Public Service Platform

 

 

 

 

 

 

Manufacturers should carefully review official publications and guidance in order to ensure that they are meeting the compliance requirements for China RoHS 2.

EU – Ecodesign Implementing Measure for Electronic Displays Approved

The revised implementing measure for electronic displays was approved by the European Commission on October 1, 2019. It establishes energy efficiency requirements and a variety of other leading ecodesign measures.

Scope

The regulation includes computer monitors, TVs and digital signage displays but excludes specialized displays including small displays (e.g. less than 100 sq. cm – such as in a mobile phones), projectors, all-in-one video conference systems, medical displays, virtual reality headsets displays integrated into military equipment. It also excludes displays that are integrated into products that are already covered by another ecodesign implementing measure – details of the scope are provided in Article 1 of the regulation.

Timeline and Conformity Assessment

The new ecodesign requirements for electronic displays will take effect for products placed on the EU market starting on March 1, 2021 with a stricter set of energy efficiency requirements taking effect two years later on March 1, 2023.

Conformity assessment needs to be either to the internal design control system set out in Annex IV to Directive 2009/125/EC or the management system set out in Annex V to that Directive.

Eco-design Requirements

In addition to the energy efficiency requirements, the ecodesign regulation also includes several “best-in-class” eco-design requirements:

  • Auto-standby mode
  • Design for dismantling, recycling and recovery
    1. Joining, fastening or sealing techniques do not prevent the removal, using commonly available tools, of the components requiring selective treatment that are specified in the WEEE Directive.
    2. Dismantling information needed to access any of the components specified in the WEEE Directive as requiring selective treatment need to be available on a free-access website
    3. In general, plastic components heavier than 50g need to be marked with the type of polymer and the flame retardant (if applicable).
    4. If the product contains cadmium (e.g. in quantum dots), the product needs to be marked with the “Cd” logo.
    5. Halogenated flame retardants are not permitted in the enclosure and stand
  • Design for repair and reuse
    1. Availability of spare parts with a maximum delivery time of 15 working days
    2. Access to repair and maintenance information
  • Information availability
    1. Latest available version of firmware must be available for a minimum of 8 years
    2. Product info sheet shall indicate guaranteed availability of software and firmware updates, spare parts, and product support.

The ban on halogenated flame retardants in the enclosure and stand was added late in the regulatory development process and has raised concern in the bromine chemicals industry.

EU – Adopts New Market Surveillance Regulation

The European Commission published Regulation 2019/1020 on market surveillance and enforcement which includes new obligations for manufacturers and sellers who are located outside the EU and sell directly to end-users. China had submitted comments on the WTO TBT notification in mid-2018 expressing concern about the proposed regulation and its impact on Chinese businesses selling into the EU. The new requirements take effect starting July 16, 2021.

The regulation was developed in response to a high rate of product non-compliances identified over the past few years, including lack of accountability with internet sales. It tightens responsibility for product compliance by ensuring that all products sold to users in the EU have an EU entity that is legally responsible.  The regulation covers products that are subject to a broad range of regulations including the RoHS Directive, REACH regulation, low voltage Directive, EMC Directive, and Eco-design Directive.

The new regulation is officially titled REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011. It is available for download from the Europa website.

In a nutshell, manufacturers and sellers outside the EU are required to designate a party within the EU to be responsible for product compliance and for performing compliance tasks.  This regulation is applicable to a broad range of Directives and regulations, including the EU RoHS Directive which puts nearly all EEE within its scope.

The regulation also puts more responsibility for compliance checks on customs authorities and mandates coordination between EU member state enforcement authorities so that information about a non-compliance found in one country is available to all countries.

Tasks of Economic Operators

Chapter II, Article 4 specifies the need for and obligations of economic operators. Paragraph 2 defines the economic operator:

    1. For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following:

(a) a manufacturer established in the Union;

(b) an importer, where the manufacturer is not established in the Union;

(c) an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer’s behalf;

(d) a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.

Paragraphs 3 and 4 describe the obligations of economic operators.

Obligations of the Manufacturer

The manufacturer is required to contract with and mandate the EU-based Authorized Representative to perform the tasks listed in the regulation. The Authorized Representative must also be given the means to fulfil their tasks and they “shall provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority”.

Distance Sales

The regulation very specifically closes a previous enforcement gap with distance sellers. Article 6 on Distance sales states: “Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale shall be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State.” The reference to “…targeted at end users in the Union” means that the obligation takes effect as soon as someone tries to sell a product in the EU – for example, this could be via a website that supports EU languages or allows the user to select shipping destinations in the EU.  Enforcement is possible even before a sale is made.

Internet Sellers and Internet Service Providers

The regulation requires Information/Internet service providers to cooperate with the market surveillance authorities and, in certain cases, to mitigate risks presented by a product.  For example, this could require selling sites to remove products or sellers.

Market Surveillance Authorities

Articles 10 to 34 of the regulation focus on the operation, powers and limitations of the market surveillance authorities. It also states the procedural rights of economic operators. A market surveillance authority in one country is also required to notify other EU member states via the Rapid Information Exchange System of any serious risks that are identified.

Article 25 puts specific emphasis on European customs authorities as having the powers and resources for enforcement. This was done to ensure that products that do not have the necessary information about an Authorized Representative can be stopped before they clear customs and are available for free movement within the EU.

International Cooperation

Article 35 of the regulation allows the Commission to “cooperate with and exchange market surveillance related information with regulatory authorities” of non-EU countries and organizations.  This information could be used, for example, to coordinate product recalls.

Recovery of costs by market surveillance authorities

Article 15 gives member states the authority for “market surveillance authorities to reclaim from the relevant economic operator the totality of the costs of their activities with respect to instances of non-compliance”. This may include the cost of testing products.

Entry into Force

Article 44 states that the requirements applicable to economic operators apply as of July 16, 2021.

[1] EU market surveillance regulation, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020

IPC-175x – Updates of IPC Supplier declaration Standards

IPC-175x is a family of supplier declaration standards used by the EEE industry to communicate information about substance and material content and other information through the supply chain. The declarations are then used by down-stream manufacturers to assess parts and materials for regulatory compliance, reporting obligations, and/or for other supply management and design control functions. Figure 1 illustrates the conceptual architecture of the IPC-175x set of standards with IPC-1751A providing the top-level framework and other IPC-175x standards plugging into it.

Figure 1: IPC-175x Family of Supplier Declaration Standards

 

 

 

 

 

The IPC-175x standards are developed by task groups in the IPC E-31 (recently changed from 2-18) subcommittee. A list of the standards with task groups and revisions/amendments is provided in Table 1.

Table 1: Revisions and Amendments of the IPC-175x Standards

IPC StandardTitleTask GroupStatus of Revisions and Amendments
IPC-1751Generic Requirements for Declaration Process ManagementE-31Rev A w/Amend 1  12/12
Rev A 2/10
Vers. 1.1 3/07
Orig. 3/06
IPC-1752Materials Declaration ManagementE-31bRev A. w/Amend 1&2&3   3/18
Rev A. w/Amend 1&2 2/14
Rev A w/Amend 1 12/12
Rev A 2/10
Vers. 1.1 3/07
Orig. 3/06
IPC-1753Laboratory Report StandardE-31jw/Amend 1 5-18
Orig. 2/14
IPC-1754Materials and Substances Declaration for Aerospace and Defense and Other IndustriesE-31kw/Amend 1 4/19
Orig. 4/18
IPC-1755Conflict Minerals Data ExchangeE-31hAmend 1  4/15
Orig. 4/14
IPC-1756Manufacturing Process Data ManagementE-31aOrig. 4/10
IPC-1758Declaration Requirements for Shipping, Pack and Packing MaterialsE-31fOrig. 3/12

The IPC E-31 subcommittee and its E-31x task groups met during the week of June 17, 2019 at IPC SummerCom to continue to evolve the standards.

IPC-1751 – Subcommittee Investigates New Schema Architecture

For the next major revision to IPC-1751B, the IPC E-31 subcommittee is planning to restructure the IPC-175x XML framework in order to better support the declaration of multiple 175x sectional declarations in a single XML file. A new XSD namespace architecture is being developed to support the new framework.

Additional information about the IPC-175x standards are available on the IPC material declaration website.

 

EU – RoHS Consultation on Substance Review and Exemption

The consultants for the European Commission have launched a public consultation on the list of restricted substances being considered for addition to the EU RoHS Directive (Pack 15).  The consultation runs from September 26, 2019 until November 7, 2019.

Substance Review and Inventory

The substances consultation focuses on updating the substance inventory (applicable to EEE) and with collecting comments on four of the seven substances that are being considered for the RoHS Directive. These substances are:

    • Indium phosphide;
    • Beryllium and its compounds;
    • Nickel sulphate and nickel sulfamate; and
    • Cobalt dichloride and cobalt sulphate.

The consultants indicated that a review of the remaining three substances will be launched later in 2019.