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:
ADR 2011 Applicable from January 2011
- Limited Quantities - new Limited
Quantity marks with quantities per inner receptacle harmonised with UN
Model Regulations and thus the IMDG Code.
- Transport documentation must be retained
by the consignor and carrier for a period of three months after the
shipment date.
- Classification criteria for
environmentally hazardous substances updated to 3rd Edition of GHS.
- New credit-card style of ADR driver's
license
Commission Regulation (EU) No 453/2010
This regulation amends Annex II of the REACH Regulation. It specifies
detailed requirements for Safety Data Sheets in the European Union,
including the use of mandatory subsection headings. It applies to all
SDS issued after the 1st December 2010 and allows a further two years to
bring existing SDS into compliance with the requirements. It also
provides for final adjustments to SDS at the end of the CLP transition
period in June 2015.
IMDG Code 2010, mandatory from
January 2012
- Adopts new limited quantity marking.
- Retention of transport documents for a
minimum of three months.
Classification, Packaging, Labelling
Regulation (EC) No 1272/2008
The regulation was published in December 2008 and introduces the UN Globally
Harmonised System for hazard communication. The 1st ATP to the
harmonised classifications in Annex VI has already been published as
Regulation (EC) No 790/2009. Manufacturers and importers of
chemicals must notify their classifications of substances to the
Classification and Labelling Inventory, which will eventually be published
by the European Chemicals Agency (ECHA) on their website.
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 had to 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.
Directive 1999/45/EC The 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. The coming years will see considerable change as
various regulatory authorities transition to this system. For example,
regulations have been enacted in the EU and a proposed regulation is
currently open for consultation in the US. Similar to transport
regulations, the core GHS publication also undergoes revision every two
years. |
