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

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.

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. 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.

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

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).

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.

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. 2. 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