Tag Archives: SVHC

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.

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

IEC62474 – Declarable Substances List Updated to Version D10.00

Version D10.00 of the IEC 62474 Declarable Substance List (DSL) and the Reference Substance List (RSL) were released on December 17, 2015. The substance lists are used globally by EEE manufacturers, suppliers, and IT solution providers as a common list of substances and substance groups that are declared throughout the supply chain.

The update includes:

  • four of five substances from the December 17, 2015 SVHC additions to the EU REACH Candidate List and
  • Changes in the reporting threshold of the four phthalate substances that were added to the EU RoHS Directive earlier this year.

The IEC 62474 data exchange format (XML schema and developer’s table) was not updated during this maintenance cycle. The database update is the final step in maintenance cycle (MC-2015-02) which was started in September 2015.

A detailed summary of the changes is provided on our IEC 62474 blog.

 

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.

 

EU REACH – 48 Substances to be Reviewed in 2015

ECHA has adopted a plan to evaluate 134 substances under the REACH regulation during the 2015-2017 timeframe. The plan, which is referred to as the Community rolling action plan (CoRAP), lists the substances that EU member states will be assessing and proposing as potential SVHCs for the Candidate List or other possible regulation under REACH. The plan contains 134 substances, 66 of which have been newly selected and 68 substances that are left over from the plan that was announced in March 2014.

Of the 134 substances, the intention is to evaluate at least 48 of the substances in 2016, another 48 substances in 2016, and 38 substances in 2017.

[1] ECHA press Release: http://echa.europa.eu/view-article/-/journal_content/title/evaluation-kicks-off-for-48-substances-in-2015

[2] ECHA proposal to the Member States: Draft Community Rolling Action Plan (CoRAP) update for years 2015-2017 http://echa.europa.eu/documents/10162/13628/corap_2015_2017_en.pdf

[3] For additional information on the March 2014 plan, see the ECD blog post at http://rohs.ca/blog/2014/03/28/march-26-2014-eu-identifies-120-substances-for-evaluation-as-possible-svhcs/

EU REACH – Consultation for Two New SVHCs

A public consultation on two new SVHC Candidate List proposals began on March 2, 2015 and will continue through April 16, 2015. The new substances proposed for addition to the SVHC Candidate List are:

  • 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)
  • 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 isomers of [1] and [2] or any combination thereof]

Assuming that no major discrepancies are identified during the consultation, the new SVHCs will likely be added to the SVHC Candidate List in June 2015.

The IEC 62474 validation team is currently assessing these substances to determine if they are constituents of EEE. The first substance is specified as a combination of two phthalates (neither of which is an SVHC) with small quantity (above 0.3%) of DnHP — this substance description is likely to be a challenge for the EEE supply chain to deal with.

SVHC Threshold based on Components – ECJ Takes First Step in Ruling

The European Court of Justice has taken a first step in ruling that the REACH SVHC concentration threshold should be interpreted based on the “Once an Article, Always an Article” principle.

In its original guidance on reporting SVHCs in articles, the European Commission suggested that the 0.1% threshold should be based on the weight of the entire article as imported or as provided to the customer. However, six countries (Austria, Belgium, Denmark, France, Germany and Sweden) disagreed with this guidance. The dissenting countries argued that an SVHC that is above the 0.1% level in any individual article (component) within a product may pose a health or environmental risk and should trigger the reporting and communication obligations for the SVHC.

The difference in opinion between the two sides created a lot of ambiguity for industry, but industry generally followed the methodology given in the EC guidance document because of the sheer difficultly in meeting the obligations based on SVHC levels in each component in the product.

Legal proceedings were launched in France and are now forcing a resolution to the standoff. The European Court of Justice (ECJ), which has the final say in matters of EU regulatory interpretation, has been asked to rule on the question. As a first step toward a preliminary ruling, the Advocate General, an official legal advisor, has delivered his opinion. The Advocate General reviewed the regulatory text as written and found that there was no legal justification for the 0.1% w/w concentration to be applied to an article that is make up of many components that are themselves articles. He recommended that the preliminary ruling by the ECJ should interpret the REACH Article 33 communication obligations and REACH Article 7(2) notification to ECHA should be based on SVHC content in each original article (component) in the product.

The Advocate General’s opinion states:

V –  Conclusion

124. I therefore propose that the Court answer the request for a preliminary ruling as follows:

(1)      If the other conditions laid down in Article 7(2) of the REACH Regulation are satisfied,

(a)      the producer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own, but were made or assembled by other producers, is required to notify ECHA if a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) is present in the entire article above a concentration of 0.1% weight by weight (w/w); and

(b)      the importer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to notify ECHA if a substance meeting the criteria laid down in Article 57 and identified in accordance with Article 59(1) is present in a component article above a concentration of 0.1% weight by weight (w/w).

(2)      The supplier of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to provide information to recipients and, on request, consumers under Article 33 of the REACH Regulation on a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) if it is present in a component article above a concentration of 0.1% weight by weight (w/w) and relevant information is available to the supplier.

If the Advocate General’s opinion is accepted by the ECJ, the impact on industry will be significant. Even manufacturers that have been collecting SVHC information from suppliers may be impacted. The declaration of SVHC content in supplier parts is typically triggered based on 0.1% weight of the part provided by the supplier.  If the supplier part is itself composed of multiple articles, an SVHC in a subpart that exceeds the 0.1% threshold may be masked.

Many manufacturers would need to develop new material and SVHC risk assessment processes and collect new material declarations from their suppliers. Contact ECD Compliance for additional information on the impact of this ruling or for assistance in developing conformity assessment procedures.