Wednesday, December 22, 2010

ECHA Issues "Last Call" for Chemical Classification and Labeling Notifications

Have you notified your substance under the EU's Classification, Labeling and Packaging regulation (CLP)?  ECHA has issued a "last call" to companies who need to notify by the January 3, 2011 deadline.  All manufacturers and importers of substances that "are hazardous" according to the CLP regulation must notify the correct classification and labeling (C&L).  They also need to prepare updated safety data sheets (SDS) to reflect the new classification and labeling requirements.

For those companies who registered their chemicals under the first REACH registration deadline of November 3, 2010, they have already complied with the CLP and do not have to notify separately (assuming, of course, that they properly reported C&L in their REACH dossiers and have passed all the completeness, business rules, and financial checks).

The January 3, 2011 deadline is especially important for companies who manufacture or import dangerous chemicals at tonnages that do not require registration until 2013 or 2018.  That is because the C&L notification must be completed now, even though their registrations won't be due for up to several years.

For anyone still needing to notify, the REACH-IT system will remain open only between the hours of 10 am and 7 pm GMT (check your local time zone equivalent) from December 27 through 30, 2010.  It then will reopen for the last 24 hours on the last submission day (Monday, January 3, 2011).

More explanations of the classification and labeling notification requirements, along with access to various notification tools, can be found on the ECHA web site.

Tuesday, December 21, 2010

ECHA Recommends 8 Substances of Very High Concern be Subject to Authorization

While most attention has been on meeting registration deadlines and dealing with the new classification and labeling scheme, the European Chemicals Agency (ECHA) has also been busy at work assessing substances of very high concern (SVHC).  Yesterday ECHA recommended the addition of 8 chemicals to the candidate list for inclusion in the authorization annex based on carcinogenicity and/or reproductive toxicity issues.
The eight substances are:
  • Diisobutyl phthalate – DIBP (toxic to reproduction). A substance used as plasticiser for nitrocellulose, polyacrylate and polyacetate dispersions;
  • Diarsenic trioxide – As203 (carcinogen). A substance used in the manufacture of glass with special properties and of zinc;
  • Diarsenic pentaoxide – As205 (carcinogen). A substance which could be used as a replacement for diarsenic trioxide, no known current uses in the EU;
  • Lead chromate (carcinogen and toxic to reproduction). A substance used as pigment and in the manufacture of pyrotechnics;
  • Lead sulfochromate yellow - C.I. Pigment Yellow 34 (carcinogen and toxic to reproduction). A pigment used to colour plastics and coatings;
  • Lead chromate molybdate sulphate red - C.I. Pigment Red 104 (carcinogen and toxic to reproduction). A pigment with similar uses as lead sulfochromate yellow;
  • Tris(2-chloroethyl)phosphate – TCEP (toxic to reproduction). A substance used as a plasticiser and viscosity regulator with flame-retarding properties for coatings;
  • 2,4-Dinitrotoluene - 2,4-DNT (carcinogen). A substance mainly used in explosives and propellants for ammunition.
The European Commission makes the final decision on the inclusion of the substances in Annex XIV of the REACH Regulation.  This now makes 46 chemicals on the candidate list waiting for addition to Annex XIV, after which they would only be eligible for continued use if manufacturers or importers applied for authorization and could show a combination of controlled use and a plan for finding substitutes.  Any authorization would be limited both temporally and with restrictions in the specific uses allowed.

More on the ECHA recommendations and the authorization process can be found on the ECHA web site.

Monday, December 20, 2010

US and Europe Agree to Share Chemical Data

Last week the USEPA, which has responsibility for managing chemicals in the US, and ECHA, which does the same in the European Union, signed a statement of intent (SOI) to share data, cooperate with each other on chemical reviews, and even exchange staff (or perhaps in this age of budget cuts, just share video-conference call links).  The SOI acknowledges all the work that ECHA and industry have done in this past few years developing a system to submit and review health and safety data under the REACH program.

According to the SOI, the scope of the planned cooperation could include:

- scientific collaboration and information exchange, in particular with regard to the registration (i.e., inventory) as well as hazard and risk assessment of chemical substances;
- exchange of operational experience as well as experience in strengthening regulatory capacities, for instance through training programmes;
- communication activities;
- active disseminaton of public information and publications related to each other’s activities;
- information exchange on matters of common interest, including emerging risks from chemical substances or guidance development; and
- sharing information and experience on risk identification, risk assessment and risk management tools and other similar products and related expertise.

Suggestions that such a SOI have been offered by both EPA and personal for the last month or two, so this shouldn't come as a surprise.  With TSCA reform in a holding pattern in the US (pending the new leadership in the House), and REACH just passing its first major data submission milestone, both groups seek to maximize the value of the data they are collecting and introduce some much needed efficiency in the chemical review process.  This is especially important now that chemicals are manufactured and traded worldwide.  Larger multinational companies and their affiliates should benefit from the likely data sharing between jurisdictions, but smaller and medium sized companies will also benefit as the costs of compliance get reduced by the economies of scale (e.g., if an assessment in Europe is accepted largely as is for the US, that would certainly save the cost of having to do essentially the same thing twice).

The SOI can be downloaded as a PDF from the EPA web site.