Tag Archives: REACH

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.

EU – REACH Candidate List Updated with Six SVHCs

On January 15, 2019, the European Chemical Agency (ECHA) added six additional substances to the EU REACH Candidate List. The new SVHC entries are listed in Table 1. The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE – SVHCs that are potential EEE constituents are shown with their typical EEE applications.  There is now a total of 197 SVHC entries on the REACH Candidate List.

The full REACH Candidate List is available on the ECHA website[1].

Table 1: REACH Candidate List - Six New SVHCS

NameDescriptionEC no.CAS no.Typical EEE Applications
1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one3-benzylidene camphor; 3-BC239-139-915087-24-8n/a
2,2-bis(4'-hydroxyphenyl)-4-methylpentane401-720-16807-17-6White crystalline powder, Raw material for epoxy resins, Raw materials for polycarbonate resin, Thermal paper, Chemicals, Surface coatings, Inks, Adhesives, Synthetic resin additives, Liquid crystal materials, Photosensitizers, Information recording agents, Engineering plastic materials, Electronic functional materials, Optical functional materials; may be used as substitute for BPA
Benzo[k]fluoranthene205-916-6207-08-9Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Fluoranthene205-912-4206-44-0; 93951-69-0Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Phenanthrene201-581-5January 8, 1985Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Pyrene204-927-3129-00-0; 1718-52-1Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers

[1] REACH Candidate List, http://echa.europa.eu/candidate-list-table

Reporting REACH SVHCs using the is Article Flag in IPC-1754 Declarations

The EU REACH regulation applies significant requirements on product manufacturers to identify substances of very high concern (SVHCs) listed on the REACH Candidate List that are present in their products. Following a European Court of Justice ruling, the European Chemical Agency (ECHA) published a guidance document clarifying that the threshold level for reporting the SVHC is 0.1% of the first article in a product and not the finished product (as suggested in earlier ECHA guidance documents).  In the REACH regulation, article is defined as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” According to the ECHA guidance, the first article is when a substance is applied such that an article is first created and not based on a complex object that is made up of individual parts that are themselves articles.

This creates challenges for product manufacturers and requires them to obtain additional information from their supply chain on whether a SVHC is present (above 0.1%) in the first article of which it is a constituent.  For compliance assessment, a key piece of information needed by downstream manufacturers is the mass percent of a SVHC in its first article.

To provide this information in a material declaration, the substance and mass relative to the first article needs to be provided.  The challenge is how to communicate this within a material declaration.

How does IPC-1754 support REACH SVHC assessment

The IPC-1754 declaration standard supports this information requirement by allowing materials and subproducts to be reported in the declaration. The data exchange format also provides an (isArticle) flag for materials, subproducts, and the product so that the supplier can identify any object in the declaration as to whether or not it is an article.  This may be either a material (that meets the defn of article) or a subproduct.

How to determine if the mass percent of a substance is above 0.1% of the article

When a substance is reported in a declaration it includes mass information – this may be either the mass of the substance or a mass percent (the mass of the substance divided by the mass of the material or subproduct (or product) that the substance is assigned to in the declaration hierarchy).  However, the recipient of the declaration may not know enough about the manufacturing of the product (or its parts) to identify the first article. It’s best if the supplier identifies this first article and passes sufficient information down the manufacturing chain for downstream manufacturers to assess compliance requirements.  For the recipient to be able to determine the mass percent of the SVHC in the first article, the supplier needs to include the first article as an object in the declaration (this could be a material, subproduct or the product) and it needs to be identified as an article.

Examples of a single SVHC in the product

Figure 1 illustrates a simple declaration hierarchy of an SVHC (S1) that is included in a material (M1) which is included in part (P1) (which is the first article). Material M1 is identified as not an article (isArticle=False) and subproduct P1 is identified as the first article (isArticle=True) therefore the recipient is able to calculate that the mass percent of S1 in the first article (P1) is 0.2g / 10g = 2% (which is above the 0.1% threshold that triggers the REACH communication requirements). The top-level product is a higher level article (may be referred to as a complex object) and therefore also has isArticle=True.

There are instances where a material may have a specific shape and meets the definition of an article (see second example in Figure 2). In this case, the isArticle flag for material M1 is set to True and the SVHC mass percent in an article is 0.2g / 1.0g = 20%.

Figure 1: Simple example of a declaration with an SVHC in an article (subproduct)

Figure 2: Example with a material that is an article

 

 

 

 

 

 

 

 

 

 

 

In both of these examples, the SVHC content is above 0.1% triggering REACH communication obligations, but there are cases where only a small amount of the SVHC is present and the selection of the first article will impact whether or not the SVHC is present above or below this threshold.  It’s up to the supplier that first incorporates an SVHC into an article to identify this to downstream manufacturers

When there are multiple SVHCs added at different stages of Manufacturing

There may also be products that include more than one SVHC. In some cases, the SVHCs may be applied at different stages during manufacturing, resulting in a complicated declaration hierarchy. One such example is illustrated in Figure 3.

  • The substance S1 (an SVHC) is included in a plating material (M1) which is applied to a lead frame (SP1) which then becomes a plated lead frame (SP2).
    • SP2 is the first article that includes S1, therefore the mass % of S1 in an article is the (mass of S1) / (mass of SP2).
    • If this mass % is above 0.1%, then S1 has REACH obligations.
  • The substance S2 (another SVHC) is a constituent of die attach material that is applied to the die (SP3) and the plated lead frame (SP2) to become the die assembly (SP4).
    • In this case, SP4 is the first article for substance S2 and is used as the basis of the mass % calculation to compare to 0.1%.
  • Overall, in this declaration hierarchy of the IC, subproducts SP4 and SP2 are both first articles for different SVHCs, which creates a complex declaration.

For the recipient of a declaration to properly assess REACH obligations, it’s necessary for the supplier to declare the material or subproduct (or product) that is the first article and identify that it as an article (by using the isArticle flag).

Note: in some cases (for simple products), the product may be the first article (e.g. the product provided by a supplier may be a single piece of molded plastic) or the product may be a mixture (e.g. wet paint) and there is no article.

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.

 

 

EU – Six Substances under Consultation as SVHCs

The European Chemical Agency (ECHA) has launched their fall consultation of additional substances for the REACH Candidate List of SVHCs. Six substances (see Table 1) have been proposed.

The IEC 62474 Validation Team is currently reviewing the substances for potential applicability to the EEE industry.

Table 1: Proposed SVHCs under Consultation

Substance_NameEC_numberCAS_number
4,4’-isopropylidenediphenol (bisphenol A)201-245-880-05-7
4-Heptylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 7 covalently bound predominantly in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof]
4-tert-butylphenol202-679-098-54-4
Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride)209-008-0552-30-7
Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts206-400-3,
221-470-5		3108-42-7,
335-76-2,
3830-45-3
p-(1,1-dimethylpropyl)phenol201-280-980-46-6

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.

 

 

 

 

Two Substances added to REACH SVHC Candidate List

The European Chemical Agency (ECHA), on June 15, 2015, added two new substances to the REACH SVHC Canadidate 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 REACH Candidate List,

Name of Substance or Substance GroupEC number CAS number
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5) 271-094-0
272-013-1		68515-51-5
68648-93-1
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] --

The first substance is a mixture of two alkyl diesters when the mixture contains greater than 0.3% of dihexyl phthlate (DnHP). This SVHC listing will likely be confusing and a challenge for industries to manage. The two primary ingredients with the CAS numbers and EC Tnumbers listed are themselves not SVHCs; the mixture only becomes an SVHC with the Article 33 reporting obligations when it includes greater than 0.3% DnHP.

The second new listing in the REACH Candidate List is a substance group. The primary example listed by ECHA of this substance group is the product sold under the name “karanal” . ECHA indicates that the main use, according to public information, is as a fragrance.

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