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.
The IPC-1754 standard titled “Materials and Substances Declaration for Aerospace and Defense and Other Industries” 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.
 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.
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;
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).
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.
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.
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 Name||EC number||CAS number|
|Perfluorononan-1-oic-acid and its sodium and ammonium salts||206-801-3||375-95-1, 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.
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.
A Canadian mandatory survey Notice, published on July 25, 2015, requires that manufacturers and importers of certain nanomaterials report to Environment Canada. The survey was published as a Section 71 Notice under the Canadian Environmental Protection Act (CEPA). It specifies a legal requirement for entities who meet the conditions specified in the Notice to report the information described in the Notice.
This information gathering approach is coordinated with the reporting requirements being launched within the U.S. The two countries undertook a Regulatory Cooperation Council (RCC) Nanotechnology Initiative starting in 2011 to increase alignment in regulatory approaches for nanomaterials between Canada and the US, so the similarity in approach and timing is not surprising.
Environment Canada described the purpose and objective of the Notice is to:
“… gather information on 206 nanomaterials identified as potentially in commerce in Canada from the primary reference list. The information collected from the Notice will support the development of a list of nanomaterials in commerce in Canada by confirming their commercial status, and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities, if required. This will ensure that future decision making is based on the best available information.”
Manufacturers and importers are required to submit a response to Environment Canada if the conditions specified in Schedule 1 and Schedule 2 of the notice are met. Schedule 1 provides a list of substances that require reporting if they meet the definition of nanoscale as provided in the notice.
For the purposes of the Notice, nanoscale means a size range between 1 to 100 nanometres, inclusive, in any one external dimension, or internal or surface structure.
There are 206 substances listed in Schedule 1. The Schedule 1 substances are shown in the Annex to this post for informative purposes only. Reporting is required if greater than 100kg of a nanoscale substance is manufactured or imported during the 2014 calendar year. The importation of the nanoscale substance is relevant whether it’s imported as in substance form, within a mixture or included in a product. The Notice states: “product” excludes “mixture” and “manufactured item”. Exemptions are provided for a few situations such as in transit through Canada, naturally occuring nanomaterials, incidental production, and some agricultural products,
The deadline for reporting is on February 23, 2016.
There are details and subtleties in the survey Notice; please refer to the Notice for the exact legal wording to assess whether or not you are required to report . The survey notice is available from the Canada Gazette part I.
Contact ECD Compliance. We can provide your organization with timely updates on global environmental regulatory requirements and can assist with the Canadian survey Notice.
The substance list is provided for general reference only. Please refer to the Notice for the official substance list.
Annex - Schedule 1 - Substances for reporting if in nanoscale form
|CAS RN||Name of the Substance|
|75-20-7||Calcium carbide (CaC2)|
|156-62-7||Cyanamide, calcium salt (1:1)|
|409-21-2||Silicon carbide (SiC)|
|471-34-1||Carbonic acid calcium salt (1:1)|
|592-01-8||Calcium cyanide (Ca(CN)2)|
|1303-00-0||Gallium arsenide (GaAs)|
|1303-11-3||Indium arsenide (InAs)|
|1303-61-3||Gold sulfide (Au2S3)|
|1304-76-3||Bismuth oxide (Bi2O3)|
|1304-85-4||Bismuth hydroxide nitrate oxide (Bi5(OH)9(NO3)4O)|
|1305-62-0||Calcium hydroxide (Ca(OH)2)|
|1305-78-8||Calcium oxide (CaO)|
|1305-79-9||Calcium peroxide (Ca(O2))|
|1306-23-6||Cadmium sulfide (CdS)|
|1306-24-7||Cadmium selenide (CdSe)|
|1306-25-8||Cadmium telluride (CdTe)|
|1306-38-3||Cerium oxide (CeO2)|
|1307-96-6||Cobalt oxide (CoO)|
|1308-04-9||Cobalt oxide (Co2O3)|
|1308-06-1||Cobalt oxide (Co3O4)|
|1309-37-1||Iron oxide (Fe2O3)|
|1309-42-8||Magnesium hydroxide (Mg(OH)2)|
|1309-48-4||Magnesium oxide (MgO)|
|1310-43-6||Iron phosphide (Fe2P)|
|1313-13-9||Manganese oxide (MnO2)|
|1313-99-1||Nickel oxide (NiO)|
|1314-06-3||Nickel oxide (Ni2O3)|
|1314-13-2||Zinc oxide (ZnO)|
|1314-22-3||Zinc peroxide (Zn(O2))|
|1314-23-4||Zirconium oxide (ZrO2)|
|1314-36-9||Yttrium oxide (Y2O3)|
|1314-87-0||Lead sulfide (PbS)|
|1314-98-3||Zinc sulfide (ZnS)|
|1317-34-6||Manganese oxide (Mn2O3)|
|1317-35-7||Manganese oxide (Mn3O4)|
|1317-37-9||Iron sulfide (FeS)|
|1317-38-0||Copper oxide (CuO)|
|1317-39-1||Copper oxide (Cu2O)|
|1317-40-4||Copper sulfide (CuS)|
|1317-61-9||Iron oxide (Fe3O4)|
|1333-84-2||Aluminum oxide (Al2O3), hydrate|
|1333-88-6||Aluminum cobalt oxide (Al2CoO4)|
|1344-28-1||Aluminum oxide (Al2O3)|
|1344-43-0||Manganese oxide (MnO)|
|1344-54-3||Titanium oxide (Ti2O3)|
|1345-25-1||Iron oxide (FeO)|
|7757-93-9||Phosphoric acid, calcium salt (1:1)|
|7758-23-8||Phosphoric acid, calcium salt (2:1)|
|7758-87-4||Phosphoric acid, calcium salt (2:3)|
|7778-18-9||Sulfuric acid, calcium salt (1:1)|
|7778-44-1||Arsenic acid (H3AsO4), calcium salt (2:3)|
|7783-96-2||Silver iodide (AgI)|
|7785-23-1||Silver bromide (AgBr)|
|7789-79-9||Phosphinic acid, calcium salt|
|7789-80-2||Iodic acid (HIO3), calcium salt|
|7789-82-4||Molybdate (MoO42-), calcium (1:1), (T-4)-|
|7790-75-2||Tungstate (WO42-), calcium (1:1), (T-4)-|
|7790-76-3||Diphosphoric acid, calcium salt (1:2)|
|9000-11-7||Cellulose, carboxymethyl ether|
|9004-32-4||Cellulose, carboxymethyl ether, sodium salt|
|9004-36-8||Cellulose, acetate butanoate|
|9004-38-0||Cellulose, acetate hydrogen 1,2-benzenedicarboxylate|
|9004-39-1||Cellulose, acetate propanoate|
|9004-41-5||Cellulose, 2-cyanoethyl ether|
|9004-57-3||Cellulose, ethyl ether|
|9004-58-4||Cellulose, ethyl 2-hydroxyethyl ether|
|9004-62-0||Cellulose, 2-hydroxyethyl ether|
|9004-64-2||Cellulose, 2-hydroxypropyl ether|
|9004-65-3||Cellulose, 2-hydroxypropyl methyl ether|
|9004-67-5||Cellulose, methyl ether|
|9005-22-5||Cellulose, hydrogen sulfate, sodium salt|
|9013-34-7||Cellulose, 2-(diethylamino)ethyl ether|
|9032-42-2||Cellulose, 2-hydroxyethyl methyl ether|
|9041-56-9||Cellulose, hydroxybutyl methyl ether|
|9051-13-2||Cellulose, hydrogen carbonodithioate, sodium salt|
|9088-04-4||Cellulose, carboxymethyl 2-hydroxyethyl ether, sodium salt|
|11104-65-7||Chromium copper oxide|
|11115-91-6||Iron manganese oxide|
|11137-98-7||Aluminum magnesium oxide|
|11138-49-1||Aluminum sodium oxide|
|12002-86-7||Silver selenide (AgSe)|
|12004-35-2||Aluminum nickel oxide (Al2NiO4)|
|12014-14-1||Cadmium titanium oxide (CdTiO3)|
|12018-10-9||Chromium copper oxide (Cr2CuO4)|
|12022-95-6||Iron silicide (FeSi)|
|12033-07-7||Manganese nitride (Mn4N)|
|12033-89-5||Silicon nitride (Si3N4)|
|12035-57-3||Nickel silicide (NiSi)|
|12035-72-2||Nickel sulfide (Ni3S2)|
|12037-47-7||Silicon phosphate (Si3(PO4)4)|
|12060-00-3||Lead titanium oxide (PbTiO3)|
|12063-19-3||Iron zinc oxide (Fe2ZnO4)|
|12068-56-3||Aluminum oxide silicate (Al6O5(SiO4)2)|
|12069-00-0||Lead selenide (PbSe)|
|12137-20-1||Titanium oxide (TiO)|
|12141-46-7||Aluminum oxide silicate (Al2O(SiO4))|
|12160-30-4||Iron potassium oxide (Fe5KO8)|
|12160-44-0||Iron potassium oxide|
|12168-85-3||Calcium oxide silicate (Ca3O(SiO4))|
|12190-87-3||Chromium titanium oxide (Cr2TiO5)|
|12214-12-9||Cadmium selenide sulfide (Cd2SeS)|
|12271-95-3||Boron silver oxide (B4Ag2O7)|
|12442-27-2||Cadmium zinc sulfide ((Cd,Zn)S)|
|12511-31-8||Silicic acid (H4SiO4), aluminum magnesium salt (2:2:1)|
|12515-32-1||Cerium tin oxide (Ce2Sn2O7)|
|12626-36-7||Cadmium selenide sulfide (Cd(Se,S))|
|12626-81-2||Lead titanium zirconium oxide (Pb(Ti,Zr)O3)|
|12687-78-4||Lead silicate sulfate|
|12737-27-8||Chromium iron oxide|
|12767-90-7||Boron zinc oxide (B6Zn2O11)|
|12789-64-9||Iron titanium oxide|
|13463-67-7||Titanium oxide (TiO2)|
|13565-96-3||Bismuth molybdenum oxide (Bi2MoO6)|
|13596-12-8||Aluminum fluoride oxide (AlFO)|
|13767-32-3||Molybdenum zinc oxide (MoZnO4)|
|13769-81-8||Iron molybdenum oxide (Fe2Mo3O12)|
|13870-30-9||Silicon sodium oxide (Si3Na2O7)|
|14059-33-7||Bismuth vanadium oxide (BiVO4)|
|14987-04-3||Magnesium silicon oxide (Mg2Si3O8)|
|16812-54-7||Nickel sulfide (NiS)|
|18820-29-6||Manganese sulfide (MnS)|
|20344-49-4||Iron hydroxide oxide (Fe(OH)O)|
|20405-64-5||Copper selenide (Cu2Se)|
|20667-12-3||Silver oxide (Ag2O)|
|21548-73-2||Silver sulfide (Ag2S)|
|22205-45-4||Copper sulfide (Cu2S)|
|22914-58-5||Molybdenum zinc oxide (Mo2Zn3O9)|
|24304-00-5||Aluminum nitride (AlN)|
|24623-77-6||Aluminum hydroxide oxide (Al(OH)O)|
|25583-20-4||Titanium nitride (TiN)|
|26508-33-8||Iron phosphide (FeP)|
|37206-01-2||Cellulose, carboxymethyl methyl ether|
|39390-00-6||Lead chloride silicate|
|50815-87-7||Sodium borate silicate|
|50922-29-7||Chromium zinc oxide|
|51331-09-0||Cellulose, 2-hydroxyethyl 2-hydroxypropyl ether|
|53169-23-6||Cerium tin oxide (CeSnO4)|
|54991-58-1||Aluminum chromium oxide|
|55353-02-1||Chromium copper iron oxide (Cr2CuFe2O7)|
|59766-35-7||Zinc oxide sulfate (Zn4O3(SO4))|
|59794-15-9||Calcium borate silicate|
|63497-09-6||Chromium cobalt iron oxide|
|64539-51-1||Zinc oxide phosphite (Zn4O3(HPO3))|
|67762-90-7||Siloxanes and Silicones, di-Me, reaction products with silica|
|67953-81-5||Octadecanoic acid, polymer with silica and trimethoxy[3-(oxiranylmethoxy)propyl]silane|
|68310-22-5||Cellulose, acetate butanoate, polymer with (chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[phenol], triethoxyphenylsilane and 3-(triethoxysilyl)-1-propanamine|
|68441-63-4||Cellulose, 2-hydroxyethyl methyl ether, reaction products with glyoxal|
|68512-49-2||Cadmium zinc sulfide ((Cd,Zn)S), copper chloride-doped|
|68583-46-0||Cellulose, methyl ether, propoxylated|
|68583-49-3||Cyclotetrasiloxane, octamethyl-, reaction products with silica|
|68583-58-4||Ethanamine, N-ethyl-N-hydroxy-, reaction products with hexamethylcyclotrisiloxane, silica and 1,1,1-trimethyl-N-(trimethylsilyl)silanamine|
|68584-81-6||Silane, trimethoxymethyl-, hydrolysis products with silica|
|68585-82-0||Yttrium oxide (Y2O3), europium-doped|
|68610-92-4||Cellulose, ether with α-[2-hydroxy-3(trimethylammonio)propyl]-ω-hydroxypoly(oxy-1,2-ethanediyl) chloride|
|68611-24-5||Phenol, polymer with formaldehyde, magnesium oxide complex|
|68611-44-9||Silane, dichlorodimethyl-, reaction products with silica|
|68611-70-1||Zinc sulfide (ZnS), copper chloride-doped|
|68784-83-8||Yttrium oxide sulfide (Y2O2S), europium-doped|
|68909-20-6||Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica|
|68937-51-9||Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, reaction products with ammonia, octamethylcyclotetrasiloxane and silica|
|68957-96-0||Cellulose, 2-hydroxyethyl ether, polymer with ethanedial|
|68987-52-0||Benzenesulfonic acid, octadecenyl-, reaction products with succinic anhydride monopolyisobutenyl deriv., tetraethylenepentamine and zinc oxide|
|68988-89-6||Silica, [(ethenyldimethylsilyl)oxy]- and [(trimethylsilyl)oxy]-modified|
|69011-08-1||Chromium titanium antimonate oxide (CrTi10(SbO3)O20)|
|71077-22-0||Benzoic acid, 2-hydroxy-, polymer with formaldehyde, 4-nonylphenol and zinc oxide (ZnO)|
|71889-01-5||Silane, chlorotrimethyl-, hydrolysis products with silica|
|71889-02-6||Silane, trichlorooctadecyl-, hydrolysis products with silica|
|72162-13-1||Cellulose, carboxymethyl ether, sodium salt, reaction products with bis[(1-oxo-2-propenyl)amino]acetic acid|
|72869-37-5||Zinc sulfide (ZnS), cobalt and copper-doped|
|81859-24-7||Cellulose, 2-hydroxyethyl 2-[2-hydroxy-3-(trimethylammonio)propoxy]ethyl 2-hydroxy-3-(trimethylammonio)propyl ether, chloride|
|85919-51-3||Cellulose, 2-hydroxyethyl methyl ether, polymer with ethanedial|
|92183-41-0||Cellulose, 2-hydroxyethyl ether, polymer with N,N-dimethyl-N-2-propenyl-2-propen-1-aminium chloride|
|98616-25-2||Cellulose, ether with α-[3-(dodecyldimethylammonio)-2-hydroxypropyl]-ω-hydroxypoly(oxy-1,2-ethanediyl) chloride|
|100209-12-9||Silane, trimethoxyoctyl-, reaction products with titanium oxide (TiO2)|
|103170-24-7||Cellulose, 2-hydroxypropyl methyl ether, reaction products with glyoxal|
|111774-28-8||Cellulose, 2-hydroxyethyl ether, polymer with N,N-dimethyl-N-2-propenyl-2-propen-1-aminium chloride, graft|
|112926-00-8||Silica gel, pptd., cryst.-free|
|112945-52-5||Silica, amorphous, fumed, cryst.-free|
|116565-74-3||Chromium lead oxide sulfate, silica-modified|
|124578-08-1||1,3-Butadiene, 2-chloro-, homopolymer, reaction products with zinc oxide|
|147868-40-4||Cellulose, 2-hydroxypropyl ether, reaction products with 1,6-diisocyanatohexane homopolymer and 2,4-TDI|
|155240-18-9||Benzenesulfonic acid, dodecyl-, reaction products with succinic anhydride monopolyisobutylene derivs., tetraethylenepentamine and zinc oxide|
|308075-23-2||Silica gel, aero-|
The IEC 62474 online database was updated on July 15, 2015. Version D9.00 of the Declarable Substance List (DSL) and the Reference Substance List (RSL) are now available for use by EEE manufacturers, suppliers, and IT solution providers. The data exchange format (XML schema and developer’s table) is now version X6.01 (this is a minor editorial revision from X6.00).
The International declarable substances list (DSL) was updated to include one of the two SVHCs added to the REACH Candidate List in June (potential use in EEE) and the Mercury thresholds from the Canadian Mercury regulation that comes into effect in November 2015.
Details of the update are provided on the IEC 62474 blog.
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 Group||EC 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|
|5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane , 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane  [covering any of the individual stereoisomers of  and  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.
The European Delegated Directive (EU) 2015/863 officially adding the four (4) Phthalate substances to the EU RoHS Directive was published today, June 4, 2015. The new phthalate restrictions take effect beginning July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments). Category 8 and 9 products have an additional 2 years and need to comply by July 22, 2021. EEE manufacturers and their suppliers now have just over four years to prepare.
The amendment adds the four phthalates shown below to Annex II (Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials) of the the RoHS Directive . A maximum concentration value of 0.1% w/w in homogeneous material was specified for the phthalates in the amendment.
Four Phthalate Substances to be Added to RoHS Directive
|Substance Name||CAS Number||Maximum Concentration
in homogeneous material
|Bis(2-ethylhexyl) phthalate (DEHP)||117-81-7||0.1%|
|Benzyl butyl phthalate (BBP)||85-68-7||0.1%|
|Dibutyl phthalate (DBP)||84-74-2||0.1%|
|Diisobutyl phthalate (DIBP)||84-69-5||0.1%|
Spare Parts and Cables
The official publication of the amendment was delayed by a few months to allow the European Commission time to add verbiage clarifying the implication on cables and spare parts. This new text aligns with the general RoHS intention to allow products to be repaired using the same parts that were used in the original product when if was first put on the EU market. The published amendment states:
The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.
Phthalates in Electrical/Electronic Toys
The amendment is also explicit that the phthalates in toys restriction in Annex XVII of the REACH regulation takes precedence over the maximum concentration levels in the RoHS Directive.
What’s the Impact? How to Proceed?
The four phthalates are already listed on the REACH SVHC Candidate List — this gives manufacturers that have REACH SVHC information from their suppliers a head start in assessing the parts and materials that require substitution. However, the different basis for calculating concentration level between REACH and RoHS (article vs. homogeneous material) will undoubtedly create some surprises.
In electrical and electronic equipment (EEE), DEHP is generally considered to be the most commonly used of the four phthalates. DBP and BBP also have known applications; whereas DIBP is considered to have minimal usage within the EEE supply chain.
The results of a study published in 2010 at the IPC APEX conference “Where are REACH SVHC in Electronic Products and Parts?” may provide some insight to the use and prevalence of these substances. The study investigated and compiled analytical test results for the initial batch of SVHCs added to the REACH Candidate List (including 3 of the phthalates just added to RoHS). The analytical testing was performed in Asia, North America, and Europe on EEE and materials typically used in EEE. DEHP was detected above the SVHC threshold (0.1% wt/wt in the article) in 64 of 391 testing results (16%). The study was focused on the REACH SVHC threshold which is based on articles. However, had the study considered a concentration threshold based on homogeneous material, the number of products above the threshold would likely have been much higher.
In the time since 2010, many manufacturers that have been trying to eliminate SVHCs from their product have removed the phthalates from external cables (where they are above 0.1% in the article); but DEHP may still be present in internal cables which are relatively small and for which the phthalate content did not trigger the 0.1% threshold based on imported article.
Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. The amendment to the RoHS Directive is posted on the Official Journal of the EU. ECD Compliance provides services to track environmental regulations and can assist in upgrading your RoHS program to address the phthalate restrictions.