Tag Archives: European Chemicals Agency

BPA – The Data Game

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Over in Europe, the Member State Committee (MSC) has agreed that the European Chemicals Agency (ECHA) should request further information on six substances. This is the first batch of substance evaluations agreed on by the MSC.

Of particular note is the now infamous BPA. BPA is a carbon-based synthetic compound. It belongs to the group of diphenylmethane derivatives and bisphenols. BPA is used to make certain plastics and epoxy resins. The MSC has determined that more information is needed in order to properly assess the world’s most notorious plastic ingredient. In the US, the FDA has reached similar conclusions.

So why did the MSC agree that ECHA should request more information on six substances? This is essentially because the currently available information is insufficient to enable adequate health and environmental risk assessments. These particular six substances listed in the Community Rolling Action Plan (CoRAP) were evaluated by Germany, France, Denmark, the United Kingdom, Belgium and Spain.

Further information on Bisphenol-A (BPA) will be requested to clarify a number of concerns. First, the MSC agreed to request a new in vitro skin absorption study to assess the risk to consumers from, for example, toys and PVC articles. Second, information on the emissions and environmental exposure of BPA will be requested in order to assess the impact on the environment. The information will help to finalize the risk assessment. It will also help to determine whether further risk management measures are needed. There are on-going studies on BPA in the US which the German authority will also take into account in the next step of the assessment on endocrine disrupting properties for humans. See also BPA and California thresholds.

Other chemicals on the list

The MSC also agreed to request further information on the reproductive toxicity of carbon tetrachloride in an extended one generation reproductive toxicity study (EOGRTS, OECD 443). (More information on worker exposure to carbon tetrachloride will also be necessary).

The MSC agreed to request further information on oligomerisation and alkylation reaction products of 2-phenylpropane and phenol (previously registered as Phenol, methylstyrenated). The information requested is a bioaccumulation study in fish to clarify the concern for potential persistent, bioaccumulative and toxic properties. A combined repeated dose toxicity (90 day) and reproductive toxicity study is also requested (EOGRTS, OECD 443) to investigate endocrine disrupting effects.

The MSC agreed to ask for further information on worker exposure to imidazole and on its reproductive toxicity effects. Information will also be requested on short-term toxicity in the environment and on mutagenicity through an in vitro study.

The MSC agreed to request further information on N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine to clarify the concerns relating to persistent, bioaccumulative and toxic properties of the substance. A soil simulation test will be requested to look at aerobic and anaerobic transformation in soil.

Finally, information will be requested on a mixture of cis- and trans- tetrahydro-2-isobutyl-4-methylpyran-4-ol to clarify concerns relating to the environment. The requested study will be a short-term growth inhibition study, followed if necessary, by a long-term toxicity study in the aquatic environment.

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.

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

REACH’s Complete List of Registered Substances

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ECHA announced its list of publishable Phase-In substances under REACH regulation that were registered as of Jan. 24, 2011.

Every product is made from substances, and substances in some articles need to be registered with the European Chemicals Agency or ECHA if the products are intended to be brought to market.  Which products?  Almost any manufactured product that has a chemical in it:  clothing, furniture, plastic cases for electronic devices, motor vehicle parts, printed circuits, as well as process manufacturing products such as pharmaceutical drugs, solder and paint.

EU REACH regulation recognizes three primary deadlines for registering substances, see REACH timeline.  The first deadline was Nov. 30, 2010.  The next two deadlines are May 31, 2013, and May 31, 2018.  The deadline depends on the tonnage band and the hazardous properties of the substance.

About 30,000 substances are expected to be available in the database after expiry of the last registration deadline in 2018.  There are currently about 1/10th of that listed, just over 3000.  It’s expected that the number of substances listed in the database will increase over time, as we’ve said before, as companies will submit more registrations dossiers as we go.

List of REACH publishable Phase-In substances

Below is a preview of the list of publishable Phase-In substances under REACH regulation.  These were substances that were registered as of Jan. 24, 2011. ECHA has published this information on Registered Substances primarily so companies can start to use the data to bolster and gauge their own internal data processes and fortify their REACH software.  The information in the database was provided by companies in registration dossiers.

Please be aware that ECHA does not verify the information before dissemination, so some viewer discretion is advised.

Notice the bottom of the page says there are 62 pages of substances.  We won’t run them all here.  To see the full list, go to the ECHA database.

Please note that the ‘Registered As’ columns in the official ECHA published list (as above) are identified as follows:
•    FULL Indicates registration under REACH Article 10 as a full dossier
•    OSII Indicates registration under REACH Article 17 as an on-site isolated intermediate (OSII)
•   TII Indicates registration under REACH Article 18 as a transported isolated intermediate (TII)
•    ‘Yes’ Indicates the substance registration under REACH is complete
•    ‘In Proccess’ Indicates a dossier on the substance has been successfully submitted to ECHA and is being processed, i.e. the completeness check results are pending

As only publishable substances are listed, the list does not contain phase-in substances where the IUPAC name is claimed confidential under REACH Art 119(2)(g).  The list also doesn’t contain substances which are non-dangerous and not listed in EINECS.

A chemical named John Doe

If you want to keep your chemical name confidential in terms of ECHA registration, you must come up with an alias. As with most things REACH-related, there is a specific methodology for this.  You must provide an adequate public name as a precondition for the acceptance of a confidentiality claim for the chemical IUPAC name.

If ECHA rejects a confidentiality claim for the IUPAC name, the IUPAC name will be published. It’s best to take the time to create a public name the correct way.

The way to derive a public name for a substance are presented in the ECHA manual. There is a process for masking of various structural elements from the IUPAC name in order to derive a public name with just one level of masking. The one level of masking keeps it simple. If you feel your chemical needs additional levels of masking, a special request and allowance can in certain circumstances be made.

The full database contains a variety of information on the substances which companies manufacture or import: their hazardous properties, their classification and labeling and how to use the substances safely.

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CLP Next Steps Include Public Inventory Lists

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CLP Regulation passed a major CLP deadline on January 3, 2011.  CLP stands for Classification, Labeling and Packaging of chemicals. It’s a legal obligation affecting manufacturers and distributors doing business in Europe.

The European Chemicals Agency, ECHA, said that 3,114,835 notifications of 24,529 substances for the Classification and Labelling Inventory, either hazardous or subject to REACH registration, were submitted by the midnight Jan. 3 deadline, as reported by Occupational Health & Safety Magazine.

For this January 2011 deadline, the most notifications came from:

  1. Germany: over 800,000.
  2. United Kingdom: over 500,000.
  3. France: nearly 300,000.

Together over 6,600 companies were notified of at least one substance.

“It went extremely well,” said Geert Dancet, Executive Director of ECHA.  “We got over three million submissions of classifications in time by the deadline [midnight, Jan. 3, 2011].  I think it’s a real success.”

Jack de Bruijn, director of risk management, said, “We will put all the information which we have received into a public version of the inventory, which we hope to have available by May of this year.  And the main aim of that inventory is actually for companies to check whether they can better self-classify their chemicals.”

The C&L inventory. The collected data will be held in a central inventory called the C&L inventory. The public version of the inventory will also include substance identifiers and any relevant specific concentration limit or multiplying factor for each substance.

According to the REACH Regulation (Article 119.1), the C&L inventory will contain

  • The classification and labeling information on substances submitted to ECHA through REACH registrations and CLP notifications.
  • A list of substances that have harmonized classification in the EU.

ECHA says that the full database will be accessible to Member State Competent Authorities, and non-confidential information in the inventory will be made public on the ECHA’s website.

“And with that increased transparency,” said de Bruijn, “we hope that we will contribute considerably to the safer use of chemicals in Europe, in particular the chemicals which are used in workplaces and by the general public.”

Again, the classification and labeling inventory will be published in spring/summer 2011.

If a company has flagged the IUPAC name confidential, and where relevant, the Agency will publish an alternative name in the public inventory.

Missed deadline. Companies that missed the deadline and are not sure what to do may contact an advisor such as Chris Nowak at Actio for ideas that are particular for each unique business situation.  To handle the situation directly — use the CLP notification web page, which is what you would use whether you’re late notifying or not.

If you missed the deadline but act quickly, penalties may be minimal or nonexistent.  ECHA wants you to notify.  There is every impetus for ECHA to make CLP notification as reasonable as possible.  Remember: this is a relatively new mind-set as well as project to manage, so no question is too small or naive.  There are few experts, so start where you are, ask questions, and share what you learn with others who are probably wondering, too.

Background on CLP. Classification, Labeling and Packaging regulation relates to chemical substances and mixtures. It introduces into the EU the criteria of the United Nations Globally Harmonised System — also known as GHS conversion — toward classifying and labeling chemicals.

One aim of the CLP regulation is to improve the protection of human health and the environment. One way of protecting human health is by publishing criteria for defining when a substance or mixture displays properties that lead to its classification as “hazardous.”

It’s too bad the CLP Regulation has such a complicated name — the concept is quite simple.

The CLP big picture is that hazardous chemicals and mixtures, when registered under REACH Regulation, require some sort of uniform classification system; this way all participants are using consistent terms, measurement units, and pictographs. Simple.

CLP is a legal obligation, yes, but it’s also common business sense.  Of course we would would want uniform communication standards in terms of classification, labels, and packaging when it comes to hazardous materials. It sounds cost-effective, too.  OSHA estimated last year that GHS, for instance, would result in time-to-market ROI, international trade cost reduction, and savings resulting from greater job safety and less injury.

Also, we should consider cost savings from lean operations resulting from streamlined processes; never mind cost-savings in time, paper and clerical labor, and the priceless ease-of-reporting to stakeholders such as the EPA, REACH agencies, any regulatory bodies, customers, board members, the public at large.

Finally,  in standard communication documents, there are significant risk management returns to consider. No entity is really resisting CLP or GHS because it makes sense from an Environment, Health and Safety or EHS angle, as well as from the business side.

Long live the green!  Both sides of it: for the environmental stewardship folks and for the Finance department.