Category Archives: Regulations

Six Substances added to REACH SVHC Candidate List – December 17, 2014

The European Chemical Agency (ECHA) added six additional substances to the SVHC Candidate List on December 17, 2014. This brings the total number of substances on the Candidate List to 161. Manufacturers, importers and distributors have communication obligations in the EU if any of their products contain one of these substances above the reporting threshold of 0.1% w/w.

REACH SVHCs Added to Candidate List on December 17, 2014

Substance_NameEC_NumberCAS_NumberReason_for_proposing
Cadmium fluoride232-222-07790-79-6Carcinogenic (Article 57 a);
Mutagenic (Article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
Cadmium sulphate233-331-610124-36-4; 31119-53-6Carcinogenic (Article 57 a);
Mutagenic (article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)223-346-63846-71-7PBT (Article 57 d);
vPvB (Article 57 e)
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)247-384-825973-55-1PBT (Article 57 d);
vPvB (Article 57 e)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)239-622-415571-58-1Toxic for Reproduction (Article 57 c)
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)--Toxic for Reproduction (Article 57 c)

In addition to the six new entries on the Candidate List, the existing entry Bis(2-ethylhexyl) phthalate (DEHP) was updated based on “Equivalent level of concern having probable serious effects to the environment (Article 57 f)”

The REACH Candidate List SVHCs are available on the ECHA website. Additional information on the REACH SVHC obligations for organizations that manufacture or ship products into the EU are available on the ECD Compliance REACH web page.

Products Containing Mercury Regulations published in Canada

The Canadian “Products Containing Mercury Regulations” were published in the Canada Gazette on November 19, 2014 and come into force on November 8, 2015. The Regulations will prohibit the manufacture and import of products containing elemental mercury or a mercury compound. Exemptions to the mercury prohibition are provided for applications that have no technical alternative – they are similar but not identical to the EU RoHS mercury exemptions. For products that contain mercury, specific labelling and marking requirements are specified in the regulations.

Scope

The Regulations apply to any product that contains mercury, including all electrical and electronic equipment (EEE) whether currently included or excluded from the scope of the EU RoHS Directive. In this regard, the Canadian Regulations have a broader applicability than the EU RoHS Directive; however, the exemptions also cover applications that are not relevant to EEE such as use of mercury in dental amalgam.

The regulations do not apply to products that are at end-of-life, waste, a food, drug, or cosmetic, veterinary biologic, pest control product, feed, fertilizer, or explosive, ores, concentrates and by-products of metallurgic operations, and on-road vehicles from the 2016 model year or earlier.

Prohibitions and Exemptions

A product that contains mercury may not be manufactured or imported unless it belongs to a product category that has a specified exemption or if a manufacturer or importer holds a permit issued under the Regulations.

The exemptions are similar to the EU RoHS exemptions but not identical. There are differences in the wording of the allowed applications and in the allowed mercury concentration. A careful comparison is needed to ensure that a product containing mercury meets the Canadian regulation.

The regulations specify additional requirements for products that are imported or manufactured with mercury (for example, under an exemption). The additional requirements include labelling, marking, information on safe use (including when a product such as a lamp breaks), and reporting of mercury quantity that is imported or manufactured.

For product uses that are not covered by an exemption, it is possible to request a permit from Environment Canada.

For additional information or assistance on the Canadian Products Containing Mercury Regulations, contact ECD Compliance.

EU – Restrictions are Focus of New Enforcement Project

The European Forum for Exchange of Information on Enforcement is developing a new enforcement project on compliance to REACH Annex XVII substance restrictions. According to the ECHA press release, the timing for the enforcement project is: “The scope and individual restrictions to be covered will be confirmed in early 2015. Inspections will then take place during 2016. The final report will become available in 2017.”

The Forum coordinates a network of EU Member State authorities responsible for REACH enforcement and is composed of one representative from each of the EU Member States.

USA – California Proposition 65 chemicals update

Several chemicals added to California Proposition 65 over the past year are coming into effect within the next few months.

One of the chemicals, the Phthalate DINP, may be used as a plasticizer in EEE. The addition of DINP to California Prop 65 has been controversial. The American Chemistry Council launched a lawsuit against the California Office of Environmental Health Hazard Assessment with respect to the addition; however, the Court will not rule before civil enforcers can begin filing notices. The deadline for manufacturers to provide the Prop 65 warning label on products that contain DINP and are potential exposure risks is December 20, 2014.

Other substances with deadlines in January-May 2015 include Trichloroethylene (TCE), Methyl Isobutyl Ketone (MIBK), Pulegone, N,N-Dimethyl-P-Toluidine.

BNST Restriction in Lubricants in EEE Approaching in March 2015

BNST (Benzenamine, N-phenyl-, Reaction Products with Styrene and 2,4,4-Trimethylpentene) has been used in lubricants in motors and other sliding mechanisms in many types of electrical and electronic products.  The substance is added to lubricants as an additive that provides performance enhancements as an antioxidant, corrosion inhibitor, tarnish inhibitor, and scavenger and antiscaling agent. BNST containing lubricants may be found in some computer storage drives and other applications with a motor.

BNST was restricted in Canada under the Prohibition of Certain Toxic Substances Regulations, 2012 beginning on March 14, 2013; however, a 2 year exemption for use of BNST as an additive in lubricants has extended the use period for applications in the EEE industry.

Although the general exemption in lubricants expires on March 13, 2015, manufacturers and importers may apply for a permit to continue manufacturing and importing products and parts (such as motors) that contain BNST in the lubricant after March 2015. Even if BNST is being designed out of new products, there is still a significant challenge for OEMs that need to continue providing spare parts for the repair of existing products — there is no exemption in the regulation for spare parts. Environment Canada requires 60 working days to process a permit application; therefore they are requesting that all applications should be submitted by no later than December 1, 2014 in order to have the permit issued on time.

The permit application includes requirements for information on BNST use and plans for phasing out the substance from your products.  Environment Canada has stated that applications not meeting specific minimum requirements cannot be approved.

The Prohibition Regulation is available for download from the Canada Gazette.

For support on completing and submitting a permit application, contact ECD Compliance.

 

 

Substances Recommended for EU REACH Authorisation List – September 1, 2014

On the heels of the 2014 addition to the EU REACH Annex XIV Authorisation List, the European Chemical Agency (ECHA) has recommended another 22 SVHCs for addition to the Authorisation List (see Table). This next round of proposed additions to Annex XIV is undergoing a public consultation from September 1, 2014 through November 30, 2014. The consultation provides manufacturers and suppliers with a heads-up of the substances that may be added to the Authorisation List in mid-2015.

The introductory text to the public consultation states that information provided by chemical manufacturers and importers in their substance registration dossiers were used to prioritize these substances.

Substance_NameEC_NumberCAS_Number
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich276-158-171888-89-6
Disodium tetraborate, anhydrous215-540-41330-43-4, 12179-04-3, 1303-96-4
Acetic acid, lead salt, basic257-175-351404-69-4
1-bromopropane (n-propyl bromide)203-445-0106-94-5
4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof]--
Bis(2-methoxyethyl) phthalate204-212-6117-82-8
Lead monoxide (lead oxide)215-267-01317-36-8
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters271-084-668515-42-4
Dipentyl phthalate (DPP)205-017-9131-18-0
Pentalead tetraoxide sulphate235-067-712065-90-6
Tetraboron disodium heptaoxide, hydrate235-541-312267-73-1
Anthracene oil292-602-790640-80-5
Orange lead (lead tetroxide)215-235-61314-41-6
Pyrochlore, antimony lead yellow232-382-18012-00-8
Diboron trioxide215-125-81303-86-2
N-pentyl-isopentylphthalate-776297-69-9
Boric acid233-139-2, 234-343-410043-35-3, 11113-50-1
Diisopentylphthalate210-088-4605-50-5
Silicic acid, lead salt234-363-311120-22-2
Tetralead trioxide sulphate235-380-912202-17-4
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear284-032-284777-06-0
Pitch, coal tar, high temp.266-028-265996-93-2

[1] ECHA public consultation on substances proposed for Authorisation under EU REACH regulation: http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list

EU REACH – Consultation of Ten Substances for SVHC Candidate List – September 1, 2014

Dossiers for 10 SVHC proposals were submitted by EU Member States in August and are now available for public consultation on the ECHA website. Only six of the proposals are for new additions to the SVHC Candidate List. The other four dossiers are proposing modifications to the existing entries for the Phthalates DEHP, DBP, BBP, and DIBP.

The four Phthalate proposals modify the reason for SVHC inclusion to include human health and environmental hazards as endocrine disrupters.

Information about the public consultation is available on the ECHA website[1]. The consultation closes on October 16, 2014. The 10 proposals under consultation are listed in the following Table.

Substances under Consultation for REACH SVHC Candidate List

Substance_NameEC_NumberCAS_NumberReason_for_proposing
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)247-384-825973-55-1PBT (Article 57 d);
vPvB (Article 57 e)
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)223-346-63846-71-7PBT (Article 57 d);
vPvB (Article 57 e)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)239-622-415571-58-1Toxic for Reproduction (Article 57 c)
Cadmium fluoride232-222-07790-79-6Carcinogenic (Article 57 a);
Mutagenic (Article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
Cadmium sulphate233-331-610124-36-4; 31119-53-6Carcinogenic (Article 57 a);
Mutagenic (article 57 b);
Toxic for Reproduction (Article 57 c);
Equivalent level of concern having probable serious effects to human health (Article 57 f)
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)--Toxic for Reproduction (Article 57 c)
Benzyl butyl phthalate (BBP)201-622-785-68-7Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f)
Bis(2-ethylhexyl) phthalate (DEHP)204-211-0117-81-7Equivalent level of concern having probable serious effects to human health and the environment(Article 57 f)
Dibutyl phthalate (DBP)201-557-484-74-2Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f)
Diisobutyl phthalate (DIBP)201-553-284-69-5Equivalent level of concern having probable serious effects to human health and the environment (Article 57 f)

[1] ECHA consultation website: http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification

Nine SVHCs added to REACH Authorisation List – August 14, 2014

The European Commission has added nine substances from the SVHC Candidate List to the REACH Authorisation List (Annex XIV). As per Article 56 in the REACH regulation, substances listed in REACH Annex XIV may not be placed on the EU market (individually or in mixtures) or used in the EU after the sunset date unless the manufacturer has been granted “authorisation”. A total of 31 SVHCs are now on the authorisation list.

There are no exempted uses listed for any of the substances. Therefore all use of the substances (in the EU) after the sunset date will require authorisation. The sunset dates vary from August 22, 2017 through January 22, 2019.

Substance NameCAS NumberSunset dateLatest application date
Dichromium tris(chromate)24613-89-622/01/201922/07/2017
Strontium chromate7789-06-222/01/201922/07/2017
Pentazinc chromate octahydroxide49663-84-522/01/201922/07/2017
Potassium hydroxyoctaoxodizincatedichromate11103-86-922/01/201922/07/2017
2,2'-dichloro-4,4'-methylenedianiline (MOCA)101-14-422/11/201722/05/2016
1,2-Dichloroethane (EDC)107-06-222/11/201722/05/2016
Formaldehyde, oligomeric reaction products with aniline (technical MDA)25214-70-422/08/201722/02/2016
Bis(2-methoxyethyl) ether (Diglyme)111-96-622/08/201722/02/2016
Arsenic acid7778-39-422/08/201722/02/2016

EU Consults on Restriction of BPA in Thermal Paper

The EU Commission is considering a restriction of bisphenol A (BPA) in thermal paper. Thermal paper is used in many electronic products that require simple printing capability such as point-of-sale terminals, label printers, lottery ticket printers and fax machines. BPA is the most common dye developer used in thermal paper. The restriction is proposed for a concentrations equal or higher than 0.02% by weight.

Alternatives to the use of BPA in thermal paper were also the subject of a U.S. EPA DfE program a couple of years ago.

The EU restriction proposal was original submitted by France. As the next step in the consideration process, the European Chemical Agency (ECHA) has launched a public consultation that runs from June 18, 2014 to December 18, 2014. Comments may be provided through the ECHA website.

RoHS Exemptions Set to Expire in Two Years

The RoHS exemptions that are listed with no expiry date in Annex III of the EU RoHS Directive (2011/65/EU) will automatically expire on July 21, 2016 for most electrical and electronic equipment unless a manufacturer or industry association comes forward with an application to renew the exemption.

Several of the Annex III exemptions are used very broadly in electronic components and systems. This includes exemption 7(c)-I “Electrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound”, 7(c) -II “Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher” and the 6(a), 6(b), and 6(c) exemptions that allow lead to be used in certain metal alloys.

Lead in Communication Products and Servers
For communication equipment and computer server, exemption 7(b) “Lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, signaling, transmission, and network management for telecommunications” is still heavily used by many manufacturers, particularly for complex printed circuit boards using large BGA devices. Significantly development work has been underway over the past decade to develop new design and soldering materials and techniques to improve the long-term reliability of these products using PB-free solders. Many manufacturers have been progressively shifting their designs to Pb-free components and soldering processes. It appears that the industry (especially large OEMs) feels that this exemption may no longer be required and it may be time to allow the exemption to expire.

However, there are still numerous products on the market using Pb solders and significant design and RoHS assessment effort will be needed to bring these and successive products into RoHS compliance for 2016.

Exemption Renewal Requests
Under the original RoHS Directive, the EU Commission would initiate studies and consultations to assess each of the exemptions and determine which required renewal and which could be allowed to expire. However, under RoHS 2, responsibility for initiating this process and providing sufficient evidence for continuing an exemption has been assigned to industry. A stakeholder (manufacturer or industry association) must submit a renewal request according to RoHS 2 Article 5 (3).

The exemption renewal request must be made at least 18 months before the exemption expires. This means that requests for renewal of Annex III exemptions must be made within the next six months; otherwise the exemptions may no longer be used in Category 1-7, and 10 products. This comes directly from the RoHS 2 Directive, Article 5, paragraph 2:

Measures adopted in accordance with point (a) of paragraph 1 shall, for categories 1 to 7, 10 and 11 of Annex I, have a validity period of up to 5 years and, for categories 8 and 9 of Annex I, a validity period of up to 7 years. The validity periods are to be decided on a case-by-case basis and may be renewed.

The validity of the exemptions for Category 8 (medical devices) and 9 (monitoring and control instruments) products is 7 years from the date that the products must be RoHS compliant; therefore these may continue to leverage the exemptions for a few more years.

To track regulatory changes including the RoHS exemptions and for support on RoHS compliance process contact ECD Compliance.