More Proposed SVHC for REACH

ECHA is proposing for public comment more candidate SVHC (Substances of Very High Concern) under REACH.   These do not trigger the Candidate List requirements – yet.  See the list here.

More arsenic, lead and chromate compounds. Ethylene dichloride. Diglyme, CAS 111-96-6, which has stirred EPA attention recently (proposed SNUR).  Most interesting is the first identified as “equivalent level of concern” because it is an endocrine disruptor and not the standard carcinogen, reproductive toxin, mutagen (4-tert-octylphenol).  Expect to see lots more EDCs (endocrine disrupting chemicals).

ECHA will keep adding to the Candidate List SVHC, making compliance an ongoing challenge for products and their raw materials.  Need help?  Contact EHS Strategies, Inc.

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REACH SVHC in Articles Controversy

France and Sweden have announced they will be enforcing REACH Substances of Very High Concern content in articles according to the “once an article, always an article” scheme.  Expect the other dissenting countries – Austria, Belgium, Germany and Norway – to follow.  Their position is that any component or part in an article that was ever a separate article should be counted for the >0.1% wt/wt calculation and not the article as a whole  (e.g., a belt buckle).  However, the official legal opinion of the EU and ECHA that the percentage refers to the entire article as marketed (e.g., the complete belt).

Expect lawsuits to straighten this out….

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REACH: New SVHC Candidates

Now there are officially 53 Candidate SVHC (substances of very high concern). The latest chemicals added:

2-ethoxyethylacetate

strontium chromate

1,2-Benzenedicarboxylic acid, di-C7-11 branched and linear alkyl esters (DHNUP)

hydrazine

1-methyl-2-pyrrolidone

1,2,3-trichloropropane

1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP)

Remember:  This trips downstream communication on the presence of >0.1% right away and within 6 months may require article notification to ECHA if import exceeds 1 metric tonne and the use hasn’t been registered yet.

Contact EHS Strategies, Inc. if you need help.

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REACH: Next SVHC List

Next up to be listed as Substances of Very High Concern under REACH:

2-ethoxyethylacetate

strontium chromate

1,2-Benzenedicarboxylic acid, di-C7-11 branched and linear alkyl esters (DHNUP)

hydrazine

1-methyl-2-pyrrolidone

1,2,3-trichloropropane

1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP)

Reminder: Notification is due today for the majority of SVHC which were listed prior to Dec 1, 2010.  Candidates with the date of inclusion listed 15.12.2010 are to be notified by June 15.  The above new chemicals musts be notified within 6 months of their official inclusion.  Keep watch on the Candidate List here.

I’ll be giving a talk on REACH and Articles June 15, 2011, for the Minnesota Trade Office and will cover the notification requirements.

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REACH: Substances in Articles Website

ECHA has established a new website to help deal with requirements for articles containing substances of very high concern (SVHC)  http://echa.europa.eu/reach/sia_en.asp

It includes guidance documents and a Q&A section.

ECHA  webinar 19 May 2011 recorded here.

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New REACH Guidance on Articles

ECHA has published new guidance on applicability of REACH for articles.  The revised guidance offers a few more examples of what an “article” is and suggestions for how to track down whether your articles contain any Substances of Very High Concern (SVHC).

Most distressing is the introductory note from the Executive Director:

“When reading this ECHA Guidance document, please be aware that it did not find full support by consulted national authorities of EU/EEA Member States in the stage of its final consultation, as reflected in the minutes that you can access via this link.

Consequently, companies may face diverging enforcement practices as to some of its aspects.” [highlight added]

They diverged on how to calculate weight percent for SVHC (reportable at >0.1 % wt/wt).  Current ECHA guidance is to look at the entire weight of the imported article, whereas some countries want to look at each component separately.  Dissenting countries: Denmark, France, Germany, Belgium, Austria, Sweden, Norway.

Reminder:  Notification to ECHA for articles with >0.1% SVHC starts June 1, 2011.  See ECHA links here.

Contact EHS Strategies, Inc. if you need help figuring out how to comply.

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REACH First Bans Announced

“Authorization” is now required for 6 formerly known as “Candidate List SVHC” chemicals listed now in REACH Annex XIV.  Uses not explicitly authorized by the sunset [ban] date  (2014 – 2015) will be off the market in Europe.  See  announcement.  The chemicals:

5-ter-butyl-2,4,6-trinito-m-xylene (musk xylene)

4,4′-diaminodiphenylmethane (MDA)

hexabromocyclododecane (HBCDD)

bis(2-ethylexyl) phthalate (DEHP)

benzyl butyl phthalate (BBP)

dibutyl phthalate (DBP)

Now what?

Authorization applications must be submitted to ECHA within 18 months of the sunset date (details to come). The Agency’s Risk Assessment Committee and Socio Economic Committee will then consider each application and submit their opinion to the European Commission. The final decision on whether any proposed continuance of a use will be allowed will be made by the European Commission. Some more info here.

It also appears that exporters to Europe cannot rely on Only Representatives to file authorizations for them.

Phthalate manufacturers may be the first ones to try for authorization: here.   Will they succeed or will customers delist the chemicals, regardless of any scientific arguments on risk?

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Next REACH Deadline: June 1, 2011 Articles with SVHC

Article Exporters: get ready for another REACH deadline.

Articles that contain >0.1% of Substances of Very High Concern (SVHC) on the REACH Candidate list (here) may require your European customers to submit a notification to the European Chemicals Agency (ECHA) by June 1, 2011.

What articles?
- Articles that contain >0.1% w/w of an SVHC that are imported by EU-based companies.
- SVHC intended to be released from the article trigger formal REACH registration for volumes >1 metric tonne.  Articles where the SVHC is not intended to be released are subject to notification only as described below.

Who reports?
- Each EU importer who produces and/or imports articles with >0.1% SVHC with a cumulative volume of >1 metric tonne/year for all articles. Each importer must add up its total volume potentially across multiple types of articles for each SVHC. This makes it difficult for you as an exporter to know whether a customer exceeds the volume trigger.

- You can contract with a EU-based “Only Representative” to file notifications for you as with registrations.

- Most likely, customers will be asking you for further information beyond just whether an SVHC is in your products.

Exemptions?
No notification is required if:

- the importer can show that there is no exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal.  No one knows yet how high this threshold is and whether anyone can meet it. At a minimum, you need to inform customers about how to safely use the article to prevent exposure.
- the importer is below 1 metric tonne SVHC for all articles it imports and produces.
- the SVHC chemical and its use in your type of article  have already been registered under REACH.  ECHA says it will be publishing non-confidential uses that have been registered.  The safest response is to contact your chemical suppliers to determine if they registered your uses.

When to notify?
- Notification requirements start June 1, 2011, for chemicals on the SVHC Candidate List for at least 6 months (prior to Jan. 1, 2011).
- Notification is triggered within 6 months of listing of an SVHC candidate. This list is updated periodically, most recently Jan. 13, 2011, with at least two new listings expected this year. This requires constant monitoring.

What to notify?
- The notice is fairly limited and ECHA is developing a reporting form; it includes a description of the article’s use, the purpose of the SVHC in the article, and volume ranges.

Further Guidance?
- ECHA has prepared a guidance document on articles subject to REACH here, as well as other documents for notification here.
- Contact EHS Strategies, Inc. for assistance.

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New REACH Guide on Authorization Applications

The European Commission has published a 120 page guide on how to file an authorization application in anticipation of the first listing of chemicals under Article XIV here

You better be prepared for a lot of work to justify continuing to use a chemical on the authorization list.  In addition to describing the use you want to maintain, you need to submit:

- a chemical safety report

- an analysis of alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant.  Gathering information for this will certainly be a challenge.

- a substitution plan including a timetable for proposed actions by the applicant for those alternatives

- if you are arguing there isn’t a risk with the use, prove it

- a socio-economic analysis if you are arguing the benefits outweigh the risks

The first list of chemicals selected from the Substances of Very High Concern Candidates will be published next week. Expected: musk xylene, MDA, phthalates DBP, BBP and DEHP and flame retardant HBCDD.  Each will get a “sunset” date after which all uses are banned unless a use is specifically authorized.

Warning to exporters to Europe: it appears that Only Representatives cannot file authorization applications for you.  You will have to work with your supply chain to protect your uses.

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New REACH Candidate SVHCs

New Substances of Very High Concern under REACH Dec. 15, 2010:  chromium trioxide, acids generated from chromium trioxide and their oligomers, cobalt(II)sulphate, cobalt(II)dinitrate, cobalt(II)carbonate, cobalt(II)diacetate, 2-methoxyethanol and 2-ethoxyethanol, which are either carcinogenic, mutagenic or reprotoxic (CMR) substances and will trigger SVHC communication requirements. See http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Authorization applications will be required for these likely additions to Annex XIV: di-isobutylphthalate (DIBP), diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulfochromate yellow (C.I. Pigment Yellow 34), lead chromate molybdate sulphate red (C.I. Pigment Red 104), tris(2-chloroethyl)phosphate (TCEP) and 2,4-dinitrotoluene (2,4-DNT).

REACH requirements do not stand still.  Watching the SVHC list is critical for compliance.  Contact EHS Strategies, Inc. if you have questions.

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