Tag Archives: REACH

REACH News: 8 New SVHC Intentions

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In REACH related news, the European Chemicals Agency (ECHA) announced recently that the Registry of Intentions of Substances of Very High Concern has been updated with eight new intentions.  The list of intentions lets companies prepare for commenting.  It also indicates it’s time to start internal process prep in the event that a listed chemical does become regulated.

The eight new intentions of SVHCs and their CAS numbers are:

  1.     Heptacosafluorotetradecanoic acid, CAS 376-06-7
  2.     Pentacosafluorotridecanoic acid, CAS 72629-94-8
  3.     Henicosafluoroundecanoic acid, CAS 2058-94-8
  4.     Tricosafluorododecanoic acid, CAS 307-55-1
  5.     Methoxy acetic acid, CAS 625-45-6
  6.     Cadmium sulphide, CAS 1306-23-6
  7.     Cadmium, CAS 7440-43-9
  8.     Cadmium oxide, CAS 1306-23-6

Obviously, cadmium is a featured intention for this, Europe’s influential chemical blacklist.  Interestingly, cadmium (along with lead) is also one of the most often requested exemptions under RoHS directive for electronics.  Just worth mentioning; may serve as reference if you’re thinking of commenting on the candidacy of cadmium for later in the process.

Pending SVHCs

As a rule, it’s important to know what is on tomorrow’s list of Substances of Very High Concern.  Best practice is know what’s pending as well as you know what’s certain.  Especially in times like these, when regulations are made bona fide and updated seemingly each week.

ECHA’s page on SVHC Intentions is here if you would like more information:  http://echa.europa.eu/registry-of-current-svhc-intentions.  Another possible action is to forward this blog post to your company’s risk management team — they will want to know.

ECHA Reveals 90,000 Chemicals

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The European Chemicals Agency (ECHA) has launched the Public Classification and Labeling (C&L) Inventory database.  Quite notably, this is the world’s largest database of self-classified chemical-substance data. Information in the database is threshed from REACH registrations and CLP notifications so far received by the Agency.

The public can freely browse or search the C&L Inventory now: http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database

But first a warning: in these first days of the new database tool, it’s recommended you begin by searching on a few chemicals you are very familiar with. This will give you a feel for the accuracy of search returns.

Another warning:  be alert to multiple and inaccurate chemical classifications.  For more on that and how errors happen, see details at asterisk at bottom, below the database preview.*

References for further reading, courtesy of REACHspot:

  1.     Public C&L Inventory: http://echa.europa.eu/information-on-chemicals/cl-inventory
  2.     C&L Inventory Factsheet: http://echa.europa.eu/documents/10162/17242/factsheet_public_classification_labeling_en.pdf

Preview:

You’ll notice the chemical inventory database is searchable by 1)substance identity or 2)substance classification.  ECHA says it expects to improve search functions — so if C&L searches seem unreliable at first, continue to check back with the database, and by all means continue to send notes to ECHA stating how helpful improved search capability would be (so their IT department can prioritize).

The Inventory is maintained by ECHA and the data will be refreshed on a regular basis with incoming and updated C&L information.

The C&L Inventory database and CLP and REACH  So you may be wondering, how does it all connect?  The C&L Inventory is a database which contains classification and labeling information on substances notified under Regulation (EC) No 1272/2008 — known as the CLP Regulation — and registered under Regulation (EC) No 1907/2006 (the REACH Regulation).  Plus, it will also contain the list of legally binding harmonized classifications (Annex VI to the CLP Regulation).

The C&L Inventory database aspires to serve multiple purposes:

  1. It is a tool for hazard communication and a source of basic information on substances placed on the market which meet the criteria for classification as hazardous or are subject to registration, for suppliers of substances, the general public and Member State Competent Authorities (MSCAs)
  2. It reveals differences in the classification and labeling of the same substance applied by different suppliers, thus pointing to the need for further discussion among companies to explore the reasons for differences and/or agree the most correct classification, evaluation needs or the need for a legally binding harmonization of a particular classification and labelling of a substance
  3. It is an important tool for hazard communication and risk management, e.g. when MSCAs assess the need for potential authorizations and restrictions of hazardous substances under REACH

Asterisk * Different classifications within C&L Inventory

ECHA says a primary goal of the C&L Inventory is to promote uniform classification of substances.  However…

However, for many substances different classifications will have been notified.  Over time this will be corrected.

Some instances of multiple or inaccurate classifications can be explained by technical errors made during the notification process (e.g. not assigning all labeling elements correctly) or slight differences in seemingly identical notifications (e.g. affected organs or route of exposure differs). However, different notifiers can also disagree on the classification of a substance based on different interpretation of scientific studies or different access to those studies.

In any case, notifiers have the legal obligation to make every effort to come to an agreed entry to be included in the inventory and inform ECHA accordingly.  (See Article 41 of the CLP Regulation, which says “each SIEF should agree on classification and labelling where there is a difference in the classification and labeling of the substance between potential registrants”…and again…. “the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory.”)

Additionally, sometimes there are different (legitimate) reasons for why notifications for the same substance have different classifications. Different compositions or impurity profiles often lead to different classifications.  Also, of course, the physical state and form of a substance is often very important when the hazards of a substance are assessed. The Public C&L Inventory displays the notified state and form but does not contain any information on composition or impurities.

And finally, technical errors made when notifying to the C&L Inventory can also lead to different classifications assignments that are inauthentic.

For awhile, these quirks will be “fair enough,” but over time they must be ironed out.  Else, there is little use in having a database at all.  Time will tell.  The potential is there, though, for a truly remarkable public tool to help solve the challenges of the chemicals in our modern world.

 

Join Kal for a moderated chat March 6 at www.printedcircuituniversity.com.

REACH Is Rolling: 20 New SVHCs With 1 Endocrine Disruptor

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There are four key takeaways from today’s REACH news that 20 new chemicals have been added to the Candidate List for a total of 73:

  1. Companies need to notify ECHA of uses around 20 new chemicals, deadline: June 2012
  2. Endocrine disruptor chemicals are making the List, thus are now targets for restriction (so look out BPA and the like)
  3. Chemicals can be put directly on the REACH Candidate List without a comment period (so be ready!)
  4. Companies need to be ready for the likelihood of SIN listers being restricted soon and without much warning.

Endocrine disruption. Today, officially, 4-tert-octylphenol was added to the REACH Substances of Very High Concern (SVHC) Candidate List.  4-tert-octylphenol was added to the Candidate List along with 19 other chemicals (listed below) for a total of 20 new substances of very high concern, octylphenol has a unique significance because it is the first Endocrine Disrupting Chemical (EDC) to be added to the REACH SVHC list.

The inclusion of 4-tert-octylphenol on the Candidate List opens the doors for the increased regulation of other EDCs.  A number of other chemicals can be classified as EDCs including:

  1. Dioxin and dioxin-like compounds
  2. Polychlorinated biphenyls (PCBs)
  3. DDT and other pesticides
  4. Bisphenol A and other plasticizers

The endocrine system includes glands and hormones which regulate vital functions including growth, sexual development and behavior, metabolism, and reproduction. According to some, such as the National Institute on Environmental Health Sciences, EDCs are chemicals that may interfere with the body’s endocrine system and produce adverse effects — developmental, reproductive, neurological, and immune system — in both humans and wildlife.  (View a comprehensive list of chemicals linked to endocrine disruption here.)

Companies can help ensure they’re prepared for any changes to the SVHC list by collecting supplier data on chemical ingredients as part of their quality assurance systems.

SVHC List REACHes 73. With 73 chemicals now listed, companies may have new legal obligations resulting from the inclusion of substances in the Candidate List. The obligations may apply to the listed substances on their own, in mixtures or in articles.  For starters:

Producers and importers of articles have six months from today to notify ECHA by 19 June 2012 if both of the following conditions apply:

  • the substance is present in those articles in quantities totaling over one tonne per producer or importer per year and
  • the substance is present in those articles above a concentration of 0.1 % weight by weight

There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded.

Among the recent 20 additions, 12 substances have been included in the Candidate List following the unanimous agreement of the Member State Committee, while the other eight did not receive comments challenging the identification as SVHC during public consultation, but were added to the list directly.

The 20 new chemicals on the REACH Candidate List are:

  1. Zirconia Aluminosilicate Refractory Ceramic Fibres
  2. Calcium arsenate
  3. Bis(2-methoxyethyl) ether
  4. Aluminosilicate Refractory Ceramic Fibres
  5. Potassium hydroxyoctaoxodizincatedichromate
  6. Lead dipicrate
  7. N,N-dimethylacetamide
  8. Arsenic acid
  9. 2-Methoxyaniline; o-Anisidine
  10. Trilead diarsenate
  11. 1,2-dichloroethane
  12. Pentazinc chromate octahydroxide
  13. 4-(1,1,3,3-tetramethylbutyl)phenol
  14. Formaldehyde, oligomeric reaction products with aniline
  15. Bis(2-methoxyethyl) phthalate
  16. Lead diazide, Lead azide
  17. Lead styphnate
  18. 2,2′-dichloro-4,4′-methylenedianiline
  19. Phenolphthalein
  20. Dichromium tris(chromate)

Companies can refer to the ECHA website for potential legal obligations resulting from the inclusion of substances in the Candidate List. If handling REACH is becoming too onerous, consider a REACH software solution or contact one of the many consultants on the subject. Consider joining an online forum of experts such as this LinkedIn Group — and communicating with colleagues about best practices in solving REACH. A little planning and foresight goes a long way, especially as REACH gets bigger and bigger.  A pandemic, as someone we all know called it.

This article was co-authored by Pat King, who holds a bachelor’s in environmental science from Saint Laurence University.

ECHA’s New Website Is Good But Not Perfect

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The European Chemicals Agency (ECHA) has finally updated its website for a more user-friendly, intuitive and let’s call it what it is: functional user experience.

The new site is easier to use, for sure.  The site still errs on the side of delivering editorials about REACH and related topics rather than providing the tools we need to execute tasks (it’s very European to want to talk more about it, while Americans want to get right to the action).

So if you’re looking for the Substance of Very High Concern (SVHC) candidate list — you’ll find a lot of pages talking about the list but you’ll pull your hair out trying to get to the list itself.  The list is here:  http://echa.europa.eu/web/guest/candidate-list-table

Tip: Google is a quicker way to find tables, tools and lists on the site rather than using the ECHA search box.  Search for “ECHA Candidate List” on both Google and ECHA — and you’ll agree.

12 new SVHCs  ECHA says committees have unanimously agreed to add 12 new chemicals of very high concern to that candidate list, so you’ll want to know where to find it.  Today, the list stands at 53 SVHCs today, also kept up to date at websites besides ECHA’s.

Overall, people will appreciate the improvements.  It’s getting better all the time, as the Beatles said.

EPA Publishes More Confidential Business Info

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Last June, EPA removed confidentiality protection for more than 150 chemicals. EPA’s declassification trend toward substance-level material disclosure is similar to the culture around chemical information in Europe under REACH and RoHS.

On Nov. 28, the agency announced the public availability of hundreds of studies on chemicals that had previously been treated as confidential business information (CBI). EPA says that over the next year the agency expects to review several thousand additional studies on industrial chemicals and make many reviews accessible to the public.

Releasing the data, says EPA, will expand the public’s access to critical health and safety information on chemicals that are manufactured and processed in the U.S.  Newly available information can be found using EPA’s Chemical Data Access Tool.

Since 2009, “What’s in your product?” is a question with over 500 answers available now that were previously unavailable. Some 577 formerly confidential chemical identities are no longer confidential and more than 1,000 health and safety studies are now accessible to the public that were previously unavailable or only available in limited circumstances. In 2010 EPA issued new guidance outlining the agency’s plans to deny confidentiality claims for chemical identities in health and safety studies under the federal Toxic Substances Control Act (TSCA) that are determined to not be entitled to CBI status. EPA has been reviewing CBI claims in new and existing TSCA filings containing health and safety studies.

“EPA is increasing the availability of critical health and safety studies on chemicals that children and families are exposed to every day. We are making important progress in making this information public and giving the American public easy access to it,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention.

For additional information, please visit: www.epa.gov/oppt/existingchemicals/pubs/transparency.html

REACH Database: Over 5000 Substances Registered

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The European Chemicals Agency (ECHA) announced Wednesday that ECHA’s Dissemination Database contains now 4413 records. In total, 5181 substances have been registered as of Nov. 3, 2011, says the agency.

There are now 3908 substances published on the list of registered publishable substances.

On ECHA’s dissemination portal, you can download information or search for substances; an excellent resource for folks looking more deeply into REACH compliance.

The next big REACH deadline is May, 2013, but ECHA is asking companies to start preparing now.

En route to the 2013 deadline, there are two key deadlines for 2012:

1. Late preregistration deadline prior to the 2013 registration deadline, for first time manufacturers and importers;

2. Downstream users should notify suppliers of uses by May 31, 2012 at the latest.

The Next Big REACH Deadline

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The European Chemicals Agency (ECHA) recently launched a campaign to remind industry to start preparing for the second REACH registration deadline, as reported by REACHspot.  We put together a few guidelines on how to prepare for the next round of REACH regulation deadlines.  Really, the next one to worry about is May of 2012.  Here’s what you need to know.

The big REACH deadline in 2013.To prepare for the REACH 2013 deadline, companies manufacturing or importing chemicals in Europe — in quantities at or above 100 tonnes per year — are required to register such substances with ECHA by May 31, 2013.

But first, find out if your substances are already registered.  To do this, simply go to the ECHA database of registered substances and search for your chemical.

If your substance meets the criteria of passing through the EU at a quantity of 100 tonnes or above and it has not already been registered, you are required to register your substance.

How to compile information to register. There are a few elements involved in compiling necessary information for registration.

  1. Substance identification and sameness of substance: confirm with the other preregistrants that you have the same substance
  2. Hazard information: collect all data available on the intrinsic properties of the substance to be registered
  3. Data sharing: as part of a joint registration, gather and share existing information, consider alternatives to testing and answer any information request from within your Substance Information Exchange Forum or SIEF
  4. Chemical safety assessment: carry out a chemical safety assessment in order to produce a chemical safety report based on the hazard information collected and knowledge on the uses

To wit:  for joint submissions, there must be a  so-called Lead Registrant who, yes, leads — and Members who follow.  The Lead Registrant is one registrant acting with the agreement of the other assenting registrant(s) who will submit the joint registration dossier with all information. ECHA recommends this is done at least 2 months before the legal deadline, which means by March 31, 2013. Members are other registrants who have confirmed their membership in the Joint Submission in REACH-IT, they have to submit their registration after the Lead Registrant within the May 31, 2013 deadline.

REACH deadlines 2012.There are 2 key deadlines for May of next year.

  1. Late preregistration deadline prior to the 2013 registration deadline, for first time manufacturers and importers. Late preregistration is a simple process. You just submit your information, via an agent, your own internal REACH software, or online using REACH-IT.  Please note that late preregistration is only allowed under specific circumstances.
  2. Downstream users should notify suppliers of uses by May 31, 2012 at the latest.

You are a downstream user if you use a substance, either on its own or in a mixture — also called a chemical cocktail — in the course of your industrial or professional activities. If you are a manufacturer or an importer of a substance, a distributor or a consumer, you are not a downstream user. Guidance is available.

Also, it’s advised that you research available tools for substance management and REACH management in particular, try a Google search for REACH software to start.

15 Bad Intentions Under REACH

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Three new restriction proposals for NPs and NPEs have been announced under REACH.  Specifically, the three are:

  1. 4-nonylphenol, branched
  2. nonylphenol
  3. nonylphenol ethoxylates

NPs and NPEs are grouped under alkyl phenols and their ethoxylates.  Sweden has proposed intentions to restrict the three substances.

Notification of intention: September 2, 2011
Expected date of submission: August 3, 2012

Currently, most substances under intention for restriction are mercury compounds and phthalates.  To view or download the list of 12 substances with intention for restriction under REACH see below or download REACH’s12 intentions.

The Swedish Chemicals Agency understands that the proposed restriction is a new restriction, not an amendment of an existing one.  (The amendment of an existing restriction requires first a decision according to REACH article 69(5) to amend the restriction and then a decision according to the normal procedure amending the restriction.)

Justification for the three new proposed market restrictions for 4-nonylphenol, branched and nonylphenol and nonylphenol ethoxylates is reportedly based on Sweden’s understanding that:

  1. NP (e.g., nonylphenol) and NPEs (e.g., nonylphenol ethoxylates) have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota
  2. NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents
  3. NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms
  4. NP has also been shown to exhibit estrogenic properties in vitro and in vivo assays. NP’s main use is in the manufacture of NPEs
  5. NPEs are nonionic surfactants that have been used in a wide variety of industrial applications and consumer products. They can be found in textile (including leather) articles
  6. NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP
  7. Levels of NP in waters above the environmental quality standards in the Water Framework Directive (WFD) is found in several waters despite the strict restriction on the use of Nonylphenol (NP) and Nonylphenoletoxilates (NPEO) under the limitations directive 76/769/EEC (now in Reach Annex XVII, entry 46) having been in force since January 2005
  8. NP and NPEO in textiles have been identified as a significant source of NP in the environment

Based on these data, the Swedish Chemicals Agency is investigating the possibility to propose a restriction on the placing of the market of textile and leather articles containing NP or NPEO.

REACH Gets A 5-Year Review

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It’s been five years since REACH* was adopted. Now, five years later, the European Commission (EC) is preparing to review the legislation.

The review is expected to be significant but not overwhelming. The EC-led review will be based on “lessons learned” from the implementation of REACH, focusing on the costs and administrative burden and other “impacts on innovation.”REACH regulation The review will include:

    1. Test method costs and spends: an audit of the amount and distribution of funding made available by the EC for the development and evaluation of alternative test methods.
    2. REACH scope: whether to amend REACH scope to avoid overlaps with other EU legislation.
    3. ECHA: a review of the European Chemicals Agency (ECHA).
    4. Lower tonnage substances: a review of registration requirements for lower tonnage substances.

‘So, how’s my driving?’ Originally, REACH sought to test, analyze, categorize and track ~100,000 chemical substances. But since 2006, only a small number of chemicals have actually been reviewed, starting with a list of 47 Substances of Very High Concern (click here for full SVHC list), which are suspected of causing cancer or disturbing the human reproductive system.

“But there are a lot more substances out there,” said Jamie Page from the Cancer Prevention and Education Society, as reported by Euractiv.

Page is calling for the screening process to be accelerated. “Obviously, there are a lot of chemicals on the market – people estimate between 80,000 and 100,000 – so it is like a few down, a lot to go.”

ChemSec, an environmental lobby group, has recently accused the EU of delaying action on “endocrine-disrupting” chemicals such as phthalates, calling on regulators to speed up work. ChemSec wants 378 substances included in the SVHC list. “There are a lot of controversial products,” Page concurred, citing Bisphenol A, a compound which has recently been banned in plastic baby bottles but which some scientists believe could be harmful in other guises, such as coatings for food cans.

Activist lawyers ClientEarth and chemicals campaigners ChemSec recently said they had sued ECHA for refusing to disclose the names of facilities producing 356 potentially dangerous chemicals. ECHA told Reuters in May it had decided to publish company names ONLY in the case of firms that are suppliers of hazardous substances, but that those entities and stakeholders could request confidentiality.

For producers of nonhazardous chemicals, the disclosure would be voluntary.

Notes: * REACH is the European regulation for the safe use of chemicals. REACH deals with the registration, evaluation, authorization and restriction of chemical substances. Adopted in 2006, it entered into force on June 1, 2007. The European Chemicals Agency (ECHA), based in Helsinki, Finland, acts as overseer of the REACH system.

REACH strives to do two things: 1) catalogue all ~100,000 chemicals in use today, and 2) set restrictions on uses of toxic chemicals.

ECHA guidance: http://guidance.echa.europa.eu/index_en.htm

REACH Guidance EZ – Documents For the Rest of Us

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Those interested in REACH regulation should know that the European Chemicals Agency (ECHA) has published a new version of its Guidance in a Nutshell.  Relevant to any company that makes, sells, buys or even thinks about finished goods, it’s called “Guidance in a Nutshell on Requirements for Substances in Articles.”

The updated “Guidance in a Nutshell” is a good document for those of us who are engineers, and who are not lawyers or overly obsessed with the finer points of Policy minutiae. The document addresses in simple terms the primary bullet points of ECHA’s new version of the Guidance on Requirements for Substances in Articles, itself something of a monster (worth wrestling with for some of us, but not all).

The Nutshell document’s aim is to help companies who produce, import or supply articles.  Specifically, it will help them to identify their obligations regarding substances in articles under REACH.  The document briefly explains key bullets such as:

  1. the concept of an article
  2. obligations for registration, notification and communication
  3. possible exemptions from these obligations

Here are the links you need:
Guidance in a Nutshell on Requirements for Substances in Articles:
http://guidance.echa.europa.eu/docs/guidance_document/nutshell_guidance_articles2_en.pdf

Guidance on requirements for substances in articles:
http://guidance.echa.europa.eu/docs/guidance_document/articles_en.htm

General ECHA guidance website:
http://guidance.echa.europa.eu/index_en.htm