ECHA to Delay Launch of CLP Classification Inventory

This just in from the European Chemicals Agency (ECHA) in Helsinki:

"ECHA has decided to delay the launching of the Classification and Labelling Inventory in order to ensure that the information provided by industry will be made publicly available in an accurate way that allows easy and functional access and navigation. The Agency will announce the new launch date by mid January. This is a key milestone project for ECHA because the public will have, for the first time, access to information on the self-classification of chemical substances by Industry."

ECHA Gives "Guidance in a Nutshell" for Identifying Chemical Substances Under REACH

ECHA, the European Chemicals Agency based in Helsinki that manages the REACH chemical registration program, has published another in its series of "Guidance in a Nutshell" documents.  This one is on the "Identification and Naming of Substances Under REACH and CLP."  More detailed guidance documents are also available, but the "Nutshell" documents provide a concise summary of the basic information needed for compliance.  According to ECHA:

The objective of the Guidance in a Nutshell on identification and naming of substances under REACH and CLP is to give guidance for manufacturers and importers on recording and reporting the identity of a substance within the context of the REACH and CLP.  It briefly explains how to name the substance and also gives guidance on whether substances may be regarded as the same in the context of those Regulations.

In addition:

This document has been drafted according to the corrigendum on Guidance for identification and naming of substances under REACH and CLP which has been published at the same time. The corrigendum includes editorial corrections, the replacement of outdated information, the correction of examples and references aiming to improve readability.

The Nutshell guidance document can be downloaded from the ECHA site here.

ECHA Risk Assessment Committee Adopts Seven Scientific Opinions

The following information comes from the ECHA web site:



The Committee for Risk Assessment (RAC) has adopted opinions on seven proposals for harmonised classification and labelling across Europe during its 17th meeting, held from 13-16 September 2011 in Helsinki.


Polyhexamethylene biguanide hydrochloride (PHMB)

RAC agreed with the proposal from France to classify PHMB as acutely toxic by the oral and inhalation route, damaging to the eye, as a skin sensitiser, as toxic to the respiratory tract after repeated exposure, suspected carcinogen and hazardous to the aquatic environment. The classification of this substance is not currently harmonised at EU level. PHMB is used as biocidal product (disinfectant).

Di-n-hexyl phthalate (DnHP)

RAC agreed with the proposal from France to classify DnHP for reproductive toxicity due to the potential for effects on unborn babies as well as on male fertility. The classification of this substance is not currently harmonised at EU level. DnHP is used in the manufacture of plastics.

Fenamiphos

RAC agreed with the proposal from the Netherlands to classify Fenamiphos as acutely toxic by the inhalation route and as an eye irritant. Fenamiphos already has a harmonised classification as acutely toxic by the oral and dermal route and as hazardous to the aquatic environment. RAC agreed with the proposal to replace the minimum classification for acute toxicity (indicate by an asterix) with the definite classification based on data. Further, RAC proposed an M-factor of 100 for chronic aquatic toxicity. Fenamiphos is used as a plant protection product.

Trichloromethylstannane (MMTC)

RAC agreed with the proposal from France to classify MMTC as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMTC as mutagenic. The classification of this substance is not currently harmonised at EU level. MMTC is used as an industrial intermediate in the production of other organotin chemicals.

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MMT (EHMA))

RAC agreed with the proposal from France to classify MMT(EHMA) as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMT(EHMA) as mutagenic. The classification of this substance is not currently harmonised at EU level. MMT(EHMA) is used as a heat stabiliser in PVC.

Benzenamine, 2-chloro-6-nitro-3-phenoxy- (Aclonifen)

RAC agreed with the proposal from Germany to classify Aclonifen as a suspected carcinogen, as a skin sensitiser and as hazardous to the aquatic environment. Aclonifen already has a harmonised classification as hazardous to the aquatic environment. Aclonifen is used as a plant protection product (herbicide).

Perestane

RAC agreed with the proposal from the UK to classify Perestane as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and as toxic to the eye after single exposure and to remove the classification for mutagenicity. Perestane already has a harmonised classification as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and mutagenic. Perestane is used as a biocide (surface disinfectant).

More information can be found on the ECHA web site.

ECHA Reports that REACH and CLP Chemical Regulations are "Working Well"

The European Chemicals Agency (ECHA) recently published two reports, both required by law, in which they conclude that despite many industry misgivings prior to enactment, the REACH and CLP regulations are "working well and that the various actors responsible for the work are responding as required." REACH is the chemical control law in Europe and the CLP is the Classification, Labeling and Packaging Regulation.  ECHA attributes the success largely to "the commitment and collaborative work between industry, stakeholders, the Member States, the European Comission and ECHA."

According to their press release, ECHA offers "three key lessons" from the experience:

•    The uncertainty over the number of registrations for the first deadline was a challenge to manage and more accurate estimates would be helpful in future.
•   Close working relationships with industry and stakeholders are vital to ensure success and the Agency can help by providing stable tools and guidance.
•    The interrelationship between the various elements of the two regulations is important and has become increasingly apparent.  For example, ambiguities in substance identification can lead to problems in forming Substance Information Exchange Fora (SIEF), evaluation and risk management activities. 

The report, which can be downloaded here as a PDF, offered recommendations for improving implementation of the laws in the future.

A second report on the implementation of efforts to reduce unnecessary animal testing can also be downloaded as a PDF here.

European Chemical Association Establishes Five REACH/CLP Platforms

The online publication, Chemical Watch, has noted that the European Chemical Industry Council, better known as Cefic, has undertaken an internal restructuring in order to best handle the changing needs of its REACH and CLP industry clients.


According to Chemical Watch, Cefic's new "platforms and their responsibilities" are:

• Registration – focusing on guidance and registration related topics for the next deadline in June 2013 and issues relating to SMEs.
• Dossier Compliance – embracing the aspects of evaluation, including the dossier compliance check and testing proposals, and enforcement.
• Restrictions and authorisation – looking at different aspects ranging from the initial proposals set out in Annex XV dossiers, through to Annex XIV Candidate List proposals and the granting of authorisations, which Mr Annys notes is now starting to be discussed in detail. He said the ECHA authorisation workshop earlier this month was a good first exchange of information and opportunity to understand what ECHA and the Commission expected companies include in their authorisation applications. He predicted that the newness and complexity of the process would likely mean the bulk of applications will come closer to the application date, rather than earlier on. He adds that the upcoming substance evaluation process, set to begin in 2012, will likely be closely related to the authorisation and restriction.
• CLP and GHS – dealing with issues such as harmonised classification and labelling, how to develop common C&Ls, and safety data sheets.
• Global Product Strategy – to fulfil industry’s commitment to meet the requirements of the Strategic Approach to International Chemicals Management

More information on Cefic's changes can be found in the Chemical Watch article (available at the above link by subscription only) and on the Cefic site.

More information about the publication, Chemical Watch, can be found on their web site.

ECHA Publishes New Guidance on Labelling and Packaging of Chemicals

The European Chemicals Agency (ECHA) last Friday issued yet another new guidance document related to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling and Packaging (CLP) regulations.  The newest guidance document "gives more details on labelling and packaging than the earlier Guidance on the Application of the CLP Criteria."

In particular, the guidance clarifies:

• what aspects to consider when estimating the label size needed;
• what types of supplemental information are possible, and where to place this information on the label;
• the conditions for small packaging exemptions;
• the interaction between CLP and the transport labelling rules;
• how to select the most appropriate set of precautionary statements for the label;
• the transitional provisions for substances and mixtures already on the market.

According to ECHA, "the new stand-alone guidance document replaces the sections dealing with labelling and selection of precautionary statements of the existing Guidance on the Application of the CLP Criteria."

The Guidance on Labelling and Packaging can be downloaded as a PDF document here.

Oops - Make that 107,067 Substances Notified, Not 24,529, Under EU Classification Scheme

Okay, so it was just a little bit off.  On January 4, 2011 the European Chemicals Agency (ECHA) announced with fanfare that 3.1 million classification and labeling (CLP) notifications had been received, and that these covered a total of 24,529 substances.  Yesterday ECHA announced, with a bit of flush to their faces, that they miscounted - the number of substances covered by those notifications was actually 101,067!

The problem stems from the rush counting (after all, the announcement was less than 24 hours after the notification deadline).  It turns out that some of the bulk files received were counted as single substances when in fact they were notifications of many distinct substances.  Hence the quadrupling of the initial substance count.

Of course, the number will continue to rise as any hazardous substance that manufacturers or importers place on the market must submit CLP notifications prior to doing so.

Several Hundred Chemicals Classified as Carcinogens, Mutagens or Reproductive Toxins under REACH

As I noted last week, the European Chemical Agency (ECHA) received 3,114,835 notifications of 24,529 substances under its Classification, Labelling and Packaging (CLP) regulation. The deadline for notifying chemical classifications was January 3, 2011.  This includes those substances notified separately as well as classifications included in the November 30, 2010 REACH registration deadline.

The REACH registration deadline was for all substances manufactured or imported in the EU at greater than 1000 metric tons per year, but also for substances that met certain "very high concern" criteria no matter what tonnage at which they were on the market.  According to the ECHA registration numbers, about 400 substances registered met the criteria for being at least one (and possibly all three) of carcinogenic, mutagenic or a reproductive toxin (called CMR for short).  Another 150 or so were considered highly toxic to aquatic life.  These "substances of very high concern" (SVHCs) will get particular scrutiny as ECHA turns to evaluating the data dossiers received.  In fact, nearly 30 of these have already been identified by ECHA in their series of candidate list proposals.  Substances on the candidate list are likely then move to the Authorization Annex of REACH, which requires manufacturers to apply for "authorization" to continue producing the substance - though any authorization will be both time-limited (with a requirement to find a substitute within a short transition period) and use-limited (i.e., will only be authorized for very specific uses in which suitable health and environmental protections will be required to limit exposure during the transition period).

The next registration deadline under REACH is June of 2013 for substances of medium levels of production and use in the EU.  But in the interim REACH is undergoing an evaluation of the program to determine if changes are needed to improve both logistics and effectiveness.  Enforcement by the member states will also now be occurring, which likely will raise other issues in need of being addressed.

ECHA says over 3.1 million chemical classification and labeling notifications received in Europe

By the January 3, 2011 deadline, the European Chemical Agency (ECHA) received 3,114,835 notifications of 24,529 substances under its Classification, Labelling and Packaging (CLP) regulation.  All of these notifications go on the C&L Inventory and are accessible on ECHA's website.  Any chemical substance that is hazardous or subject to registration under REACH were required to be notified.  In their press release, ECHA Executive Director Geert Dancet noted:

This is a perfect start for the International Year of Chemistry. The Classification and Labelling Inventory, which will be publicly available later this year, will significantly improve safety by providing up-to-date information on all the hazardous substances that are on the EU market today.

Many manufacturers and importers notified as part of their REACH registration that was due November 30, 2010.  But others who produced or imported less than 1000 metric tons per year, and thus have either a 2013 or 2018 REACH registration deadline, were also required to notify if their substances or mixtures were classified as hazardous according to the CLP.

As expected, the big three chemical manufacturing countries in the EU - Germany, the UK and France - were the source of the greatest number of notifications.  Between them they accounted for over half of all the notifications received.

What if you missed the deadline for notification? Do it NOW!  ECHA has provided some Q&A on the C&L Inventory and notification procedures if you haven't do so already.

More details on the notifications can be found in this PDF.

ECHA Lets You Search REACH-Registered Substances - Is Your Chemical Legal?

November 30th has passed and (hopefully) all of the chemical substances pre-registered at manufacture or import above 1000 tonnes per year have now been registered (if not, realize that you cannot be manufacturing or importing them in Europe).  Now ECHA has made available a searchable database of information on registered substances. According to ECHA, 

The information in the database was provided by companies in their registration dossiers. You can find a variety of information on the substances which companies manufacture or import: their hazardous properties, their classification and labelling and how to use the substances safely, for example. 

In total (as of earlier this week), there had been 19,182 REACH registrations and over 1.4 million classification and labeling notifications.  Classification and labeling for substances must now be done in Europe in accordance with the new Classification, Labeling and Packaging Regulation (CLP), which implements the globally harmonized system (GHS) of classification and labeling the EU (needless to say "globally harmonized is more than a little bit of a misnomer given it is hardly harmonized globally).

More Than 1/2 Million Chemical Classification Notifications Received by ECHA

Along with REACH registrations, companies in Europe must notify all their chemicals under the new "European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures" (CLP). The CLP is how the United Nations’ Globally Harmonised System (UN GHS) for classifying and labelling chemicals is being implemented in Europe.  Companies must notify by January 3, 2011, and as of now more than 500,000 notifications have been received by ECHA.

Companies who must register their substances by the fast approaching November 30, 2010  REACH registration deadline will also include CLP classifications, and this meets the obligation to notify.  However, those companies who make substances at lower tonnages and have 2013 or 2018 REACH registration deadlines must still notify under the CLP by January 3, 2011.  In short, "if you are a manufacturer or importer, you must notify hazardous substances that you place on the market on their own or contained in hazardous mixtures above certain applicable concentration limits, regardless of the annual tonnage manufactured or imported, as well as substances subject to registration under REACH and that you place on the market, to the Classification & Labelling Inventory established at the Agency."

More information on the CLP and the upcoming deadlines can be found on the ECHA web site.

ChemCon Americas Conference Debates REACH, TSCA Reform, GHS

This past week has been the ChemCon Americas conference in Philadelphia, where mostly industry representatives, regulatory experts, and scientists get together to discuss important issues affecting the chemical industry.  And this week was no exception.  Hot topics included the scramble to make the November 30th REACH deadline, the confusion over how various countries are implementing (or not implementing) GHS, and the uncertainty over what may or may not happen with TSCA reform in the United States.

Representatives from EPA continued to make the case that the 34-year old Toxic Substances Control Act just does not give them the authority to efficiently review tens of thousands of existing chemicals grandfathered onto the TSCA Inventory (for later review). With the chairmanships of the House set to switch from the Democratic Waxman and Rush to "Republicans to be named later," there still seems to be the belief that some form of TSCA reform will happen in the next Congress.  Meanwhile, a lawyer representing industry interests reminded attendees that the individual states are pressing forward with their own versions of reform, perhaps presenting industry with an even more complicated patchwork of regulations to monitor.

REACH also received attention.  A representative from the European Chemicals Agency (ECHA) encouraged companies to keep on pushing to meet the fast approaching deadline.  Tens of thousands of registrations have been received and many more are expected in the mad rush during the next two weeks.  Oh, and then there is the CLP - Europe's version of the Globally Harmonized System for classification and labeling, for which companies must notify all of their chemicals by January 3rd (even those not scheduled for REACH registration until 2013 or 2018).  And let's not forget Turkey. And China and Japan. And New Zealand and Australia.  And cosmetics?

No wonder everyone looks a little knackered.

European Chemicals Agency Expects "Millions" of Classification and Labeling Notifications

Manufacturers and importers of chemicals in Europe have been pretty busy lately finalizing their extensive registration packages for REACH.  At least those that must meet the November 30, 2010 registration deadline for high production volume and substances of very high concern.  But the European Chemicals Agency is reminding everyone not to forget another looming deadline - notification under the regulation on Classification, Labelling and Packaging (CLP).

With the first deadline for notifications being January 3, 2011, just one month after the first REACH registrations are due, ECHA is concerned that companies will forget about this other obligation.  The CLP regulation requires "all chemical companies operating in the EU market...to classify and label their hazardous substances according to the CLP rules."  All notifications go into a central inventory database maintained by ECHA.  And ECHA is estimating that there will be millions (yes, millions) of notifications, which includes information on hazard that will go onto labels of substances and mixtures.  Also included are a standard set of "pictograms, signal words, hazard statements and precautionary statements" that will "allow manufacturers, importers, downstream users and distributors to easily share information on the hazards of substances and mixtures."

 More information on the CLP requirements and how to notify ECHA can be found on ECHA's CLP page.  Click on the listings in the left hand column for specific guidance and time lines.

European Chemicals Director - Don't Forget the CLP Deadline for REACH!

The first REACH registration deadline is coming (November 30, 2010), and everyone is working hard to prepare registration dossiers, communicate with SIEFs, and get their documents in on time. But European Chemicals Agency (ECHA) Executive Director Geert Dancet reminded people attending a REACH conference in Helsinki - "Don't Forget the CLP."

CLP is, of course, the new Classification, Labeling and Packaging regulation in Europe. It implements the European version of the Globally Harmonized System of classification and labeling. And the deadline for notification for the CLP is January 3, 2011, just about a month after the first REACH registration deadline.

Companies that are registering in November will most likely be including the CLP notification as part of their registration package. But registrations are due only for those chemicals produced in amounts greater than 1000 tons per year and/or are considered substances of very high concern (SVHCs). Companies who produce or import smaller tonnages won't have to register their chemicals until 2013 or even 2018.

But the CLP notifications are due by January for all chemicals. And while ECHA anticipates anywhere from 25,000 to 75,000 registrations this year, they expect to see about 2 million notifications relating to the CLP. Each one of those CLP notifications requires companies to say whether their chemicals would be classified as dangerous according to dozens of different measures, including physical-chemical properties, whether they are CMRs (carcinogens, mutagens, or reproductive toxins), PBTs (persistent, bioaccumulative and toxic), or toxic to aquatic organisms.

Of the 2 million notifications expected by the beginning of the year, so far ECHA has received only 1,000.

Clearly companies have a lot of work still to do!