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.

IEC/TC111 – New Project on Material Circularity

In October 2019, the IEC/TC111 committee will be launching a new project team to develop a guidance document on material circularity for the EEE industry. In the medium to long term, this may lead to additional supply chain communication requirements for tracking the use of recycled materials and reused parts in new product manufacturing.  The first meeting is scheduled for October 21, 2019 in Shanghai, China.

EU – ECHA Provides Data Requirements for SVHC in Articles (SCIP) Database

On September 9, 2019, the European Chemical Agency (ECHA) provided the specification with information requirements for the WFD (Waste Framework Directive) Database that manufacturers will need to use to submit information on SVHCs in their products.  ECHA is now referring to this as the SCIP Database. Manufacturers whose products are sold into the EU and contain an SVHC — which is true for most EEE products and large machinery, vehicles, etc — will need to submit information about their products into the database or provide information to importers/distributors for submission. The submission duty becomes mandatory as of January 5, 2021.

In the latest document, ECHA has modified some of the terminology that was used in earlier proposals, but otherwise the technical data requirements are similar to an earlier draft specification from May 2019.

The information requirements require manufacturers to submit information about the overall product (complex object) and the first article/component containing the SVHC (ECHA is now referring to this first article as “Article as such”). ECHA has summarized the requirements as:

Besides administrative contact details, suppliers of articles need to provide the following information to ECHA:

      • information that allows the identification of the article;
      • the name, concentration range and location of the Candidate List substance(s) present in that article; and
      • other information to allow the safe use of the article, notably information to ensure proper management of the article once it becomes waste.

ECD Compliance has been providing comments to ECHA on the data requirements, material categories, and IT system on behalf of our clients.  We will continue to provide input as the database is developed and to participate in ECHA SCIP User Groups.

We are already working with our clients (manufacturers, suppliers and solution providers) to help setup supply chain communication, IT systems and data collection in preparation for the January 5, 2019 deadline to meet the obligation.  Starting the process as soon as possible is critical to success and on-going compliance with EU regulations.  Contact ECD Compliance to discuss how we can help your organization.

China – Clarification of China RoHS Mark for Self Declaration

China’s State Administration for Market Regulation (SAMR) clarified the specific mark to be applied by suppliers (e.g. manufacturers and importers) for China RoHS compliance when the self-declaration method is used. The information was provided in SAMR announcement No. 32 of 2019[1], issued on 2 July 2019. It indicates that the supplier compliance label to be used when companies use self-declaration is as shown in Figure 3.

Figure 3: China RoHS Compliance Mark for Self-Declaration

 

 

 

 

 

 

 

This is a change from what had been suggested by SAMR in their May 16th publication of “Implementation Measures on a Conformity Assessment System for the Restricted Use of Hazardous Substances in Electrical and Electronic Products”.

The Implementation Measures requires that companies choose either: Voluntary Certification; or Company Self-declaration and implement the conformity assessment requirements and apply the appropriate mark from November 1, 2019.

The vector image of the logo can be downloaded from the Green Product Identification Information Platform (www.chinagreenproduct.cn)

[1] SAMR announcement No 32 of 2019, http://gkml.samr.gov.cn/nsjg/rzjgs/201907/t20190703_303174.html

Four additional substances and substance groups to the EU REACH Candidate List

We occasionally distribute Information Bulletins with important regulatory or standards related information. The following information has just become available:

The European Chemical Agency (ECHA), on July 16, 2019 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. The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE – SVHCs that are possible EEE constituents are shown with their typical EEE applications.  There is now a total of 201 SVHCs on the REACH Candidate List.

The IEC 62474 DSL will be updated later this week. TNPP will be added as the only SVHC that realistically could be a constituent of EEE above the threshold.

The full REACH Candidate List is available at: http://echa.europa.eu/candidate-list-table

Substance NameDescriptionCAS no.EC no.Examples of use(s) (ECHA)Typical EEE Applications
2-methoxyethyl acetate110-49-6203-772-9Not registered under REACH.n/a
Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)--Primarily used as an antioxidant to stabilise polymers.stabilizer and antioxidant in the processing of various plastic materials such as PVC, Polyolefines or rubbers
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halidescovering any of their individual isomers and combinations thereof--Processing aid in the production of fluorinated polymers.n/a
4-tert-butylphenol98-54-4202-679-0Used in coating products, polymers, adhesives, sealants and for the synthesis of other substances.n/a

Sweden – Increases Tax on Electronics with Flame Retardants

The Swedish tax law (Act 2016:1067) on electronics containing flame retardants was revised by the Swedish Ministry of Finance to increase tax rates and update the products included within the scope of the law.  The law requires that a tax be paid on certain EEE products when they are placed on the market in Sweden; however, a tax reduction is available if the products can be shown to not contain bromine, chlorine or phosphorus.  Swedish Law 2019:489 amending the Tax on Chemicals in Certain Electronics Law 2016:1067 was published on June 26, 2019.

The law uses the Combined Nomenclature (CN) customs codes to determine which products are in scope.  Section 3 of the law, which sets out the products that must pay the tax, is updated and includes the CN codes shown in Table 1.

Table 1: Products included in scope of Swedish Tax Law (Act 2019:489)

Product CategoryCN Codes and Products
18418 10 (Combined refrigerator-freezers, fitted with separate external door), 8418 21 (compression type household refrigerators), 8418 29 (other refrigerators), 8418 30 (chest type freezers not exceeding 800 litres) and 8418 40 (upright type freezers not exceeding 900 litres)
28422 11 (household dishwashers)
38450 11 (fully automatic household or laundry washing machines including machines which both wash and dry of a dry linen capacity not exceeding 6kg), 8450 12 (other fully automatic household or laundry washing machines including machines which both wash and dry with built in centrifugal drier) and 8450 19 (other fully automatic household or laundry washing machines including machines which both wash and dry),
48451 21 (machines for washing, cleaning, drying, ironing etc textile yarns, fabrics, or other support used in the manufacture of floor coverings of a dry linen capacity not exceeding 10kg)
58471 30 (Portable automatic data-processing machines weighing not more than 10kg), 8471 41 (data-processing machines comprising in the same housing at least a central processing unit and an input and output unit) and 8471 49 (other portable automatic data-processing machines)
68508 11 (vacuum cleaners with self contained electric motors of a power not exceeding 1500 W and having a dust bag or other receptacle capacity not exceeding 20 L)
78516 50 (electric instantaneous or storage water heaters and immersion heaters and 8516 60 (other ovens, cookers, cooking plates, boiling rings, grillers and roasters),
88517 11 ( line telephone sets with cordless handsets), 8517 12 (Telephones for cellular networks or for other wireless networks), 8517 18 (Other apparatus for the transmission or reception of voice, images or other data, including apparatus for communication in wired or wireless network) and 8517 62 (machines for the reception, conversion, and transmission or regeneration of voice images or other data including switching and routing apparatus)
98519 30 (turntables / record decks), 8519 50 (telephone answering machines), 8519 81 (sound reproducing apparatus including cassette players not incorporating a sound recording device) and 8519 89 (other magnetic, optical or semi conductor media)
108521 10 (magnetic tape type video recording or reproducing apparatus) and 8521 90 (other video recording or reproducing apparatus),
118527 12 (pocket size radio cassette players), 8527 13 (other apparatus combined with sound recording or reproducing apparatus), 8527 19 (radio broadcast receivers not capable of operating without an external source of power used in motor vehicles) , 8527 91 (other combined sound recording or reproducing apparatus housing one or more loudspeakers), 8527 92 (clock combined sound recording or reproducing apparatus) and 8527 99 (printed circuit board sub assemblies)
128528 41 (Cathode-ray tube monitors of a kind solely/principally used in an automatic data processing system of heading 84.71), 8528 49 (other monitors), 8528 51 (other monitors), 8528 59 (projectors), 8528 71 (reception apparatus for television not designed to incorporate a video display or screen) , 8528 72 (other colour) and 8528 73 (other monochrome), and
139504 50 (video game consoles and machines).

For a taxable good referred to in categories 1–4, 6 or 7 of Table 1, the tax payable is increased from SEK 8 to SEK 11 per kilogram of the net weight of the taxable good (not exceeding SEK 440  per taxable good).

For a taxable good referred to in categories 5 or 8–13 of Table 1, the tax payable is increased from SEK 120 to SEK 160 per kilogram of the net weight of the taxable good (as above, up to a maximum tax of SEK 440 per taxable good).

An official list of taxable goods, along with their corresponding CN codes, can be found on the Swedish Tax Agency website[1]. The amendment enters into force on 1 August 2019.

[1] Swedish Act, https://www.svenskforfattningssamling.se/sites/default/files/sfs/2019-06/SFS2019-489.pdf

EU – RoHS Phthalate Restrictions take Effect Starting July 22, 2019

EEE Manufacturers are reminded that the phthalate restrictions for DEHP, DBP, BBP, and DIBP are in effect for any EEE products in RoHS categories 1-7, 10, and 11 that are placed on the market starting July 22, 2019.

Name of SubstanceCas No.
Bis(2-ethylhexyl) phthalate (DEHP)117-81-7
Dibutyl phthalate (DBP)84-74-2
Benzyl butyl phthalate (BBP)85-68-7
Diisobutyl phthalate (DIBP)84-69-5

The new EU RoHS requirements are applicable based on when individual product units are “placed on the market”.

Impact on EEE Manufacturers

Organizations that meet the definition of ‘Manufacturer’ under the EU RoHS Directive and have products that are in scope of the new phthalate restrictions should confirm that they are meeting all obligations listed under the EU ROHS Directive Article 7 (Obligations of manufacturers).  This includes updating the technical documentation to demonstrate that the four phthalate substances are not in the product above the 0.1 mass% of homogeneous material threshold.

Repair and return systems may also need to be updated to ensure that any RMA units shipped to customers in the EU either (1) meet the new substance restrictions, or (2) were previously been placed on the EU market before the new restrictions came into effect.

ECD Compliance can provide assistance with compliance to the new phthalate restrictions.