BPA – The Data Game

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.

REACH News: 8 New SVHC Intentions

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:REACH-ECHA-SVHC-list

  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

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:

CL Inventory database CLP REACH 90 000 chemicals

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 Gets A 5-Year Review

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

ECHA Updates Criteria for Accredited Stakeholders

Ever wondered what it takes to become an accredited stakeholder in the eyes of ECHA, the European Chemicals Agency, which is the governing body of REACH regulation?

A stakeholder is defined within ECHA as “an individual, group, institution or government with an interest or concern, either economic, societal, or environmental, in a particular measure, proposal or event.”

ECHA´s Management Board just revised the criteria that defines how stakeholder organizations are granted an accreditation with ECHA.  Here are the five eligibility criteria for so-called Accredited Stakeholders, as amended:

Criteria 1 – Established in and for the EU

An entity seeking status as an accredited stakeholder must be legally established within the EU/EEA and have activities at the EU level.  This means that an eligible organisation has to be legally established in one of the EU Member States, Iceland, Liechtenstein or Norway.  EU level activities are activities targeted at an EU-wide audience, i.e. not limited to the local, national or regional level. To prove it, the place of legal establishment may be evidenced by the founding document or any other suitable document proving that the entity’s seat is located in the EU, Iceland, Liechtenstein or Norway. (Organisations can explain the scope of their activities in the application form.)

Criteria 2 – Legitimate interest

The entitiy must have a “legitimate interest” in the areas of work of ECHA. This means that the organisation applying for accredited stakeholdership represents a sector affected by the EU chemicals legislation (such as the REACH, CLP, Biocides or PIC Regulation) falling within the scope of the tasks of ECHA. An organisation is also considered to have a legitimate interest in the areas of work of ECHA if it represents a sector indirectly affected by the legislation; this can also include non-governmental organisations (NGOs) engaged in issues affected by the mentioned legislation.  Typcially, ECHA’s Accredited Stakeholders are active in industry, human health, animal welfare, environmental protection, scientific research and development, and consumer protection.  Organisations are expected to depict their legitimate interest in the application.

Criteria 3 – Representative

The entity must be “representative” in the field of their competence.  This means the organization must represent the interests of a substantial part of the actors in its field of competence.  ECHA’s Accredited Stakeholders should be representative of actors in their sector or field of competence.  The necessary number of member organisations and their size depends on the structure of the relevant sector.  (Note: the sector need not have a particular size, but must be distinguishable from other sectors with different fields of interest.)  Organisations are expected to set out why they can be considered “representative” in the application form.

Criteria 4 – Non-profit

Entities must be “non-profit” and not exclusively represent individual companies.  A non-profit organisation here means one which is not operating for its own commercial profit or gain but conducts its operations for the benefit of its members or of the general public.
Non-profit status may be evidenced by the founding document or any other suitable document and must be provided during the application process.

Criteria 5 – Register

Organization must be registered in the Register of Interest Representatives maintained by the European Commission. This criterion only applies in cases where the organization wishes to participate as an observer in the Committee and Forum meetings of ECHA. There is no charge to register, it’s necessary for tracking the flow of information.

All organizations are requested to indicate their registration number in the application form.

Note:  all accredited stakeholders who wish to attend ECHA Committee and Forum meetings need to sign up in the Transparency Register, which is operated by the European parliament and the European Commission.

Useful Web Page for REACH Compliance

ECHA CHEM is a web page on the ECHA web site, itself notoriously difficult to navigate. However, it must be said that improvements are appearing. The ECHA CHEM page is nearly comprehensible!  While intuitive may still be some ways off, at least extracting information about REACH on this page is not painful. For readers interested in REACH news and REACH compliance tools, we are running this breakdown.

ECHA CHEM in a nutshell. The REACH Regulation (or REACH pandemic?) provides that various types of information submitted to ECHA or documents that are produced as an outcome of different REACH processes are to be published on the ECHA website. Under the ECHA CHEM web section you will find public information and documents from REACH processes as they become available.

Registry of intentions. This Registry provides information on the Intentions of the Member States to submit proposals for harmonised Classification and Labelling of substances, proposals for identification of Substances of Very High Concern, and proposals for restrictions.

List of pre-registered substances. The REACH Regulation requires that ECHA will publish by Jan. 1, 2009, a list of substances which have been preregistered between June 1 and Dec. 1, 2008.

Authorisation. The two first steps of the authorisation procedure are the identification and inclusion in the “Candidate List” of Substances of Very High Concern, and the prioritisation of substances to be included in Annex XIV of REACH (the “Authorisation List “).

Candidate List of Substances of Very High Concern for Authorisation. In the framework of the authorisation process, Member States Competent Authorities or the ECHA, on a request by the Commission, may prepare Annex XV dossiers for the identification of substances of very high concern. The outcome of this identification procedure is a list of substances (“the Candidate List”), which are candidates for eventual inclusion in the List of Substances Subject to Authorisation (Annex XIV of REACH).

Annex XIV recommendations
. The REACH Regulation requires that ECHA identifies from the “Candidate List” priority substances to be included in Annex XIV of REACH (the “Authorisation List”) and then recommends Annex XIV entries for these substances to the European Commission. ECHA submitted its first recommendation to the European Commission on June 1, 2009.

Information from registration dossiers. ECHA is publishing information on substances and their properties from the registration dossiers submitted to ECHA.

Transitional measures regarding existing substances. The REACH Regulation provides transitional measures for certain existing substances under Regulation (EEC) No 793/93. These substances were prioritized due to being produced in large quantities or having possible persistent, bioaccumulative and toxic properties.

ECHA publishes the Annex XV transitional reports on priority substances submitted by the EU Member States. For some substances, manufacturers and importers need to submit additional information to the Member State Competent Authority in charge. Updated assessments and so-called “voluntary risk assessment reports” will also be published there.

See it all:  http://echa.europa.eu/chem_data_en.asp

CLP Next Steps Include Public Inventory Lists

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.

EPA, ECHA Enter Partnership for Chemical Data Sharing

Arguably the two top environmental acronymn heavyweights, the US Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA) have just announced a partnership that will promote enhanced technical cooperation on chemical management activities.  This is another sign that America’s revamping of chemical regulation known as TSCA reform will likely become more REACH-like and more solidified.  The question is, how soon?

ECHA is the agency that implements the European Union’s chemical management program known as REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals).  The REACH regulation has taken the world by storm.  EPA said in a release that the newly-announced partnership is part of EPA’s commitment to “improve chemical safety.”

One of the major anticipated areas of collaboration, say the agencies, will be on the exchange of data and information.

For example, the statement of intent will promote the exchange of non-confidential information on hazards, uses, and substance identification between ECHA and EPA, including data collected under REACH and by REACH software.  The two agencies will also share criteria for managing confidential business information with the goal to increase the availability of chemical information to the public.

Overall this joining of efforts and sharing of best practices is probably a good idea.  We just hope for more efficiency rather than another dimension of beurocracy.  For more on this, see details at the EPA page.

Revamped eChemPortal for Access to Over 600,000 Chemicals

The Organisation for Economic Co-operation and Development (OECD), in partnership with ECHA, has launched its newest version of eChemPortal. Also known as the Global Portal to Information on Chemical Substances, eChemPortal provides free public access to over 600,000 records on chemical substances.

The revamped portal, hosted and funded by ECHA, includes the ability to search participating databases by chemical property (i.e., physical chemical properties, environmental fate and behavior, ecotoxicity and toxicity).

The ECHA dissemination database, US Environmental Protection Agency (EPA) Aggregated Computational Toxicology Resource (ACToR), US EPA Integrated Risk Information System (US EPA IRIS), and the United Kingdom Coordinated Chemicals Risk Management Programme Publications (UK CCRMP Outputs) are among 19 participating databases that gather information on existing chemicals, new industrial chemicals, pesticides, and biocides.

New web links provide information according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), including the GHS classification of an estimated 1,500 chemicals stored by the Japanese government.

Visit eChemPortal’s Help page for more information on using eChemPortal.

http://www.actio.net/default/index.cfm/actio-blog/revamped-echemportal-dec-2010/