Author Archives: Walter Jager

ECD Compliance Launches EU SCIP Database Services

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.

Four Substances Added to the REACH Candidate List — January 2020

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 nameECCASExamples of use(s) (ECHA)
Diisohexyl phthalate276-090-2 71850-09-4Not registered under REACH.
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone404-360-3119313-12-1The substance is used in polymer production
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one400-600-671868-10-5The 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).

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 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.

IEC 62474 Declarable Substance List Updated on January 15, 2019 with New REACH SVHCs

The IEC 62474 Declarable Substances List was updated on January 15, 2019, the same day that ECHA updated the EU REACH Candidate List with six additional Candidate List SVHCs.  The IEC 62474 Validation Team found that that five of these six substances are potential constituents of EEE. Details of the update are provided on the IEC 62474 blog posting.

IPC-1754 Substance Declaration Standard Published

The IPC-1754 standard titled “Materials and Substances Declaration for Aerospace and Defense and Other Industries”[1] was recently published by IPC.  It’s a new standard that establishes requirements for exchanging material and substance data for products between suppliers and their customers for Aerospace and Defense, Heavy Equipment and other industries.

This standard covers the process for exchanging data on substances that may be present in materials in the product and substances that may be used in production, operations, maintenance, repair or overhaul/refurbishment.

IPC-1754 was developed to meet the broad range of requirements of Aerospace, Defense and several other industries that were involved in the development of the standard. The standard includes several innovative features to support compliance assessment against a variety of substance regulations and other uses such as obsolescence management. Features to assess compliance to EU REACH and similar regulations (including the ability to identify articles in the declaration hierarchy) were particularly important.

Some of the new features include:

  • support for declaring chemicals used in manufacturing and maintenance processes (more on this in  future posts);
  • flags to identify articles (as defined in the REACH regulation), homogeneous materials, and to indicate that this is a full substance declaration (FSD/FMD)  and/or includes all materials;
  • support for declaring that some information is “unknown”;
    • The unknown capability was especially added to help suppliers in industries that are new to material and substance declarations to provide information to downstream manufacturers,
  • use descriptors (more information coming in future posts)

IPC-1754 enables an external authority such as an industry association to specify external lists that provide the basis for a declaration by a supplier to a downstream requester. This includes the declarable substance list, a query list, and optionally a use descriptor list established by the declaration Authority. The Query List (QL) provides a set of product statements (also referred to as queries)  — the supplier answers each statement with either a “true”, “false” or “unknown”.  An example of such a statement is that the product contains a substance in the Declarable Substance List (DSL). The supplier than answers true or false depending on whether a DSL substance is included or not.

ECD Compliance was extensively involved in developing IPC-1754. Our principal consultant is a co-chair of the committee.  For information on the IPC-1754 standard, how it can be used by your organization, or other support to use the standard, contact ECD Compliance.

A joint press release on IPC-1754 by IPC and the International Aerospace Environmental Group is available.

[1] Note: This is the approved title for IPC-1754. The title in the published standard is incorrect.  A title that is several revisions out of date was inadvertently inserted during publication.  IPC is aware of the issue.

 

 

Canadian Mercury Regulations – Part 3 – Exemptions

In part 1 (Products Containing Mercury Regulations published in Canada) and part 2 (Canadian Mercury Regulations to Impose Tight Restrictions on Mercury in Batteries) of our series of articles on Canadian Products Containing Mercury Regulations we discussed the scope of the regulations and maximum concentration limits for batterieis and other products and how they compare to the EU RoHS Directive and the EU Battery Directive.  In this part 3 of the series we will look at mercury exemptions, harmonized standards for product testing and spare parts. There are still numerous applications, particularly with mercury containing lamps whereby mercury is critical to proper functioning of the product.

Prohibitions and Exemptions

Under the Canadian Regulations, a product that contains mercury may not be manufactured or imported in Canada unless there is an applicable exemption or if the manufacturer or importer holds a permit issued under the Regulations. The exemptions are listed in the Schedule to the Regulations and each entry includes the product category, the maximum total quantity of mercury in the product, and the end date of the exemption.

The exemptions are similar to the EU RoHS exemptions but not identical. In general, the Canadian exemptions are more flexible, allowing slightly higher levels of mercury content for lamps. For example, item 2(a) of the Schedule specifies that a compact fluorescent lamp for general lighting purposes (≤ 25 Watts) may have up to 4 mg of total mercury per lamp. The comparable exemption in the EU RoHS Directive (exemption 1(a)) allows up to 2.5 mg of mercury per burner (this was originally 5 mg but was reduced to 3.5 mg in 2012 and then 2.5 mg as of January 1, 2013).

The applications (product categories) specified in the exemptions do not align perfectly between the two regulatory instruments, so manufacturers will need to perform a careful comparison to ensure that a product containing mercury meets the Canadian Regulations.

A renewal of most of the EU RoHS exemptions will occur in 2016 and it’s possible that the EU maximum allowable mercury levels will decline further.

The Canadian Regulations provide exemptions for other product categories that are not exempted under the EU RoHS Directive. Other exempted products relevant to the electrotechnical industry include:

  • Scientific instrumentation for the calibration of medical devices or for the calibration of scientific research instruments;
  • Scientific instrumentation used as a reference for clinical validation studies;

Product Testing

For determining the level of mercury content in products, the Canadian Regulations references IEC 62321-4:2013, entitled Determination of certain substances in electrotechnical products — Part 4: Mercury in polymers, metals and electronics by CV-AAS, CV-AFS, ICP-OES and ICP-MS, which is also referenced by the EU RoHS harmonized standard for technical document (EN 50581).

Spare Parts

The Canadian Regulations provide an exemption for replacement parts – this is similar to the EU RoHS exclusion for spare parts.

Technical support on environmental product regulations

ECD Compliance provides manufacturers and suppliers with services to track global environmental product requirements and assess the impact to their products and markets, including the Canadian Products Containing Mercury Regulations.

IEC 62474 – Updated to Align with “Article” Interpretation for SVHCs

The IEC 62474 Declarable Substance List (DSL) was updated (D11.00) on March 28, 2016 to reflect the September 2015 European Court of Justice (ECJ) interpretation of the term “article”. The ECJ ruling is important for OEMS and suppliers in determining whether a REACH Candidate List SVHC is above the 0.1 mass% threshold that triggers communication and notification obligations under the EU REACH regulation.

With the ECJ ruling addressed, the new “ReportingLevel” field, which was recently added to the database, was populated.  The ReportingLevel field is intended to simplify for users the interpretation of the more complex reporting thresholds. Some of the reporting thresholds are difficult to interpret because of how they are written in the regulation.

There were a couple of additional minor changes were made to declarable substance groups and reference substances.

A more comprehensive summary is provided in our IEC 62474 blog.

Contact us for additional information on how ECD Compliance can assist your organization in using IEC 62474 for environmental compliance.

 

EU – REACH SVHCs added to Candidate List on December 17, 2015

The European Chemical Agency (ECHA), on December 17, 2015, added five new substances to the REACH SVHC Candidate List. The substances are listed in the table below. The Article 33 communication obligations specified in the REACH regulation (Regulation (EC) No 1907/2006) came into effect as soon as the SVHCs were added to the Candidate List,

SVHCs Added to the REACH Candidate List on December 17, 2015

Substance NameEC numberCAS number
1,3-propanesultone214-317-91120-71-4
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)223-383-83864-99-1
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)253-037-136437-37-3
Nitrobenzene202-716-098-95-3
Perfluorononan-1-oic-acid and its sodium and ammonium salts206-801-3375-95-1, 21049-39-8, 4149-60-4

The substance, Dicyclohexyl phthalate, had been proposed for addition to the Candidate List during this update, but was withdrawn by the dossier submitter (Sweden) and postponed to a later submission date. The substance hexamethylene diacrylate (hexane-1,6-diol diacrylate) had also been proposed for the REACH Candidate List but did not get added. The full Candidate List is available on the ECHA website.

For additional information on developing or assessing an effective REACH SVHC compliance program, contact ECD Compliance.

EU Judgment – SVHC Reporting Required for First Article

SVHC obligations for products imported into Europe have just become significantly more complicated. Manufacturers will need to start tracking and reporting SVHC content in components in their product to comply with today’s European Court of Justice (ECJ) ruling,

The ECJ issued its anticipated judgment on the contentious issue of interpretation of ‘article’ within the EU REACH regulation as it relates to SVHC reporting and communication requirements. The changes are captured in the last few paragraph of the “Judgment of the Court (Third Chamber)”:

On those grounds, the Court (Third Chamber) hereby rules:
1. Article 7(2) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, as amended by Commission Regulation (EU) No 366/2011 of 14 April 2011, must be interpreted as meaning that, for the purposes of application of that provision, it is for the producer to determine whether a substance of very high concern identified in accordance with Article 59(1) of that regulation, as amended, is present in a concentration above 0.1% weight by weight of any article it produces and, for the importer of a product made up of more than one article, to determine for each article whether such a substance is present in a concentration above 0.1% weight by weight of that article.

2. Article 33 of Regulation No 1907/2006, as amended, must be interpreted as meaning that, for the purposes of application of that provision, it is for the supplier of a product one or more constituent articles of which contain(s) a substance of very high concern identified in accordance with Article 59(1) of that regulation in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question.

In developing its ruling, the court did not find a legal basis in the REACH regulation for an article to lose its status as an article when it is assembled into a more complex product.  This “no longer an article” principle had been the basis of ECHA’s guidance for calculating percent SVHC based on the entire weight of the finished imported article. Therefore, the court ruled that all articles must meet the requirements specified in the REACH regulation.

The court ruling confirms the first article interpretatation advocated by France, Belgium, Germany, Denmark, Sweden, Norway, and Austria. The implication being that SVHC reporting and communication obligations associated with an article do not disappear when an article is included as a component in a larger, complex article.  This suggests that manufacturers and importers must assess the SVHC concentrations in each article of a complex product and, in turn, meet the communication, notification and authorisation obligations based on this determination.

ECD Compliance provides services to assess your compliance requirements for EU REACH and other global environmental regulations and to implement compliance procedures.