Recent Changes
Update of hazard determination and
communication regulations is a dynamic process that is driven by
developments in technical progress, availability of new data and the desire
to achieve greater harmonisation between systems. The most important recent
changes are summarised as follows:
REACH Regulation (EC) No 1907/2006
After considerable discussion and negotiation, the final REACH
regulation was published in the Official EU Journal on the 18th December
2006. This requires manufactures and importers to go through a process
for
- registration,
- evaluation and
- authorisation of chemicals,
subject to
quantity thresholds.
A Fundamental element is that all existing
chemicals being placed on the EU market in excess of 1 Ton per enterprise
per annum must now be registered. Registration requires the submission of the same type of information as was previously only required for notification of new substances
i.e. substances placed on the market after 1981. Responsibility for
registration rests with the Manufacturers of chemical substances in
the EU and Importers who import either substances or products
containing substances from outside the EU. Non-EU manufacturers may
appoint an EU-based Only Representative to prepare registrations on
their behalf, and thus maintain access to EU markets.
Various phase in period are
allowed, depending on the quantities and hazards involved. Potential
registrants must Pre-register between 1st June 2008 and 1st
December 2008 in order to avail of the phase-in period and have the
opportunity to share registration costs with other registrants. The first
elements of the regulation already came into force on 1 June 2007, with the
introduction of an altered format for Safety Data Sheets, whereby the order of
information in sections 2 and 3 are reversed. Many Safety Data Sheets
will require further changes as a result of industry-harmonised
classifications, or the annexing of Exposure Scenarios, once Chemical Safety
Assessments / Chemical Safety Reports have been completed for the
registration of substances in excess of 10T/yr.
ADR 2007 Applicable from January 2007
- Introduced restrictions by tunnel
categories for carriage of dangerous goods through tunnels
- New symbol for Class 5.2 organic
peroxides
- Classification of Class 3 and Class 6.1
harmonised to GHS criteria
Directive 2004/73/EC
The 29th Adaption to Technical Progress of the Dangerous Substances
Directive 67/548/EEC
- This directive introduced the latest
changes to Annex I, the list of official EU classifications of
substances. It includes significant changes to the classification of
some substances e.g. Toluene a solvent widely used in paints and adhesives
is changed from R 11-20 to R 11-38-48/20-63-65-67.
Directive 2001/59/EC The 28th Adaption to Technical Progress of the
Dangerous Substances Directive 67/548/EEC
- Introduced separate risk phrases for Category 3 carcinogens and mutagens
R40 may cause cancer.
R68 risk of irreversible effects
- Provided more stringent guidelines on the use of extreme pH as a means of
predicting the corrositivity of substances and preparations
Directive 1999/45/EC The ‘New’ Dangerous Preparations Directive
- Classification of preparations on the basis of environmental hazards is now
mandatory. (previously only physical and health hazards had to be considered)
- Labelling requirements expanded by introducing new ‘special’ phrases that
may be necessary even when a preparation is not classified as dangerous e.g.
declaration that a preparation contains sensitisers or that SDS are available
to profession users.
- Safety Data Sheets required for preparations not classified as dangerous
that contain in an individual concentration of
-
1 % or more by weight for non-gaseous preparations or
-
0,2 % or more by volume for gaseous preparations
at least one substance posing health or environmental hazards, or one
substance for which there are Community workplace exposure limits.
The Future!
Globally Harmonised System A UN sponsored initiative has culminated in the
publication of a Globally Harmonised System (GHS) for hazard identification
and communication. It is anticipated that this will be universally
adopted starting in 2008. Legislative proposals have been published in
Europe and the US. |
