Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH)
Note:Chemical companies will, for the first time, have to start providing basic health and environmental safety data on all chemicals produced or imported before 1981. (Currently, only 3% of all known chemicals require such data.)
The scope of REACH does not cover all 100,000 known existing chemicals. Those produced in the highest volumes and those known to have dangerous properties will be dealt with first. After 11 years (from 2016) REACH will be fully implemented and safety data on approximately 30,000 chemicals will be made available.
The REACH process will identify extremely hazardous chemicals and give them special classification as ‘substances of very high concern’. These newly identified chemicals, which will be few in number (estimated at below 5%), will require a special licence for each specific use. This licence will be called an ‘authorisation’. One of REACH’s goals is to ensure that chemicals of very high concern are phased out and replaced by suitable, safer alternatives.
A chemical is classified as being of ‘very high concern’ if it causes cancer, damages genetic material, interferes with the body’s hormone system or is a reproductive toxin. Any chemical that cannot be broken down by nature and builds up in the bodies of human beings or wildlife is also classified as being of very high concern.
A significant number of chemicals likely to be classified as ‘substances of very high concern’ are present in a variety of consumer products. Greenpeace-commissioned research found nonylphenol (which disrupts hormones by mimicking oestrogen) in children’s pyjamas, toys, household paints and cleaners. Brominated flame-retardants (which can interfere with thyroid hormones) are to be found in computers, televisions, carpets and upholstered furniture. Phthalates (which can damage the liver, kidneys and testicles) are in perfume, shampoos and PVC plastics.
The scope of the definition ‘very high concern’ should be welcomed as it includes:
* Chemicals that accumulate in our bodies and the environment and are known to be toxic (PBT -- persistent, bio-accumulative and toxic).
* Chemicals that accumulate in our bodies and the environment but are not yet known to be toxic (vPvB -- very persistent, very bio-accumulative).
* Chemicals that are of equivalent concern, including endocrine-disrupting chemicals.
REACH promises significant health benefits. A recent study estimated that it could lead to Europe-wide savings of upto 283 billion Euro, based on medical costs and lost productivity as a result of diseases thought to be linked to chemicals in the environment.
REACH is a new European Regulation on chemicals and their safe use. It deals with
the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The
new law entered into force on June 1, 2007.
The objectives of REACH are:
To ensure a high level of protection from the risks that chemicals may pose to human health and the environment, through the generation and dissemination of information on chemicals, in particular safety information.
To support a sustainable and competitive EU chemicals industry that can innovate more easily and whose products meet high safety standards. This will increase consumer confidence, reduce liability risks and improve workers’ health. Downstream users will enjoy much of the same benefits and know more about the chemicals they use.
Compliance with the global commitment agreed at the 2002 World Summit on Sustainable Development in Johannesburg ‘to achieve, by 2020, that chemicals are used and produced in ways that lead to a minimisation of significant adverse effects on human health and the environment’. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.
The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers
and importers will be required to gather information on the properties of their
chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki, Finland.
The Agency will act as the central point in the REACH system. It will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.
The Regulation also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified. REACH has been developed in a climate of transparency and consultation. The Commission has held extensive dialogue
with stakeholders before and after the proposal was presented.
REACH introduces new obligations for industry, the most important one being “no data no market”. In practice, thismeans that chemical substances manufactured or imported in quantities of one or above one metric tone/year/manufacturer or importer need to be registered at ECHA.
In order to benefit from transitional deadlines (November 30, 2010, May 31, 2013 or May 31, 2018, depending on the tonnage in which they are manufactured or imported), manufacturers or importers of substances that have long been on the market (“phase-in substances”) are stronglyrecommended to pre-register their substances between June 1, 2008 and December 1, 2008. Pre-registration also enables registrants to share data with other registrants and avoid unnecessary testing.
REACH does not affects companies outside the EU directly, but your exports may be concerned if you or your customers export to any of the EU Member States or to Iceland, Lichtenstein and Norway, which are part of the European Economic Area and planning to transpose REACH into their national legislation. When this has taken
place, the same requirements apply to exports to these countries.
Exports falling under REACH are: chemical substances (e.g. base chemicals, specialty chemicals, metals, natural substances if they are chemically modified) or mixtures (“preparations”) of chemical substances (e.g. cleaningproducts, formulated process chemicals, paints, motor oils) or substances or preparations in containers (e.g. printer
cartridges) or articles which contain substances which are intentionally released during their use (e.g. fragrance in a scented candle) or contain substances which are on a candidate list of “substances of very high concern”.
This list may become available at the ECHA website from autumn 2008. If your EU importer or your only representative fails to meet the deadline for pre-registration (between June 1, 2008 and December 1, 2008), he can not benefit from the extended registration deadlines and will need to register the substance before importing it again into the EU market.
Substances which were not pre-registered but are imported for the first time into the EU after December 1, 2008 (end of pre-registration deadline) may benefit from the staggered registration timelines if the information requested for pre-registration is provided within six months of first import into the EU and no later than 12 months before the relevant registration deadline.
Registration obligations and how to fulfill them are explained in detail in the REACH guidance documents on the ECHA website. ■
This is an extract from EU India Update Vol 8 No 3- May-June 2008
For more information visit: www.echa.europa.eu www.ec.europa.eu/enterprise/reach
Although a step in the right direction, REACH is likely to fail to secure these aims because:
* Safety information requirements for only two-thirds of all chemicals would be insufficient.
* The loophole allows the continued use of chemicals of very high concern in consumer products despite the availability of safer alternatives.
* Excessive business secrecy prevails over the public’s right to know about chemical safety.
* The above shortcomings, and other get-out clauses, are unlikely to boost innovation or create regulatory predictability -- both pre-conditions to enhancing competitiveness.
A US study, Toxic Ignorance, prepared by the Environmental Defense Fund (EDF), raised a variety of concerns about the untested chemicals which are manufactured and imported into the U.S. It found that baseline data on health effects were not publicly available for many high production volume chemicals. EPA prepared its own study, titled the Chemical Hazard Data Availability Study, which found similar results and reinforced the need for government leadership on this issue. Echoes of these studies found reverberations throughout the world.
The OECD countries which includes the USA, EU, and Japan have undertaken programs to assess the impact of commercial chemicals in their High Production Volume(HPV) Chemicals Program. The US through their HPV Challenge Program has raced ahead and compiled robust literature data on nearly 1500 chemicals. The information database is now structured and peer reviewed, perhaps for the first time in history. Test programs have been devised to fill in the gaps in information. Similarly the EU has drawn robust summaries on high volume chemicals through the IUCLID programs. The UN GHS program, which is implementable by 2008 globally, calls for a certain minimal degree of chemical testing including environmental testing.
In response to global regulatory programs such as REACH the Ministry of Chemicals & Fertilizers in conjunction with the Indian Chemical Manufacturers Association (ICMA) formed three sub-group task forces.
1) The first task force looked at the framework needed by India to respond to the global regulatory programs. This included setting official responses and views from India. It will also co-ordinate the activities of other task forces.
2) The second task force looked at the development of GLP laboratories throughout India.
3) The third task force sought to develop India as a hub for IT based Services under REACH.
Following reports are available online:
1. Consumer product tests: the results
2. The health impacts of man-made chemicals -- an overview
3. Chemicals within reach -- the principle of substitution
4. Consuming chemicals -- hazardous chemicals in house dust
5. European chemicals policy reform -- from paralysis to action
6. A new chemicals policy in Europe -- new opportunities for industry
7. Chemicals under the spotlight: From awareness to action
8. International Council of Chemical Associations (ICCA) HPV working list, August 2003 http://www.cefic.be/activities/hse/mgt/hpv/hpvinit.htm
9. US HPV Challenge Program http://www.epa.gov/chemrtk/volchall.htm
10. Euopean Union IUCLID Program http://www.epa.gov/chemrtk/volchall.htm
11. UN GHS website: http://www.unece.org/trans/danger/publi/ghs/ghs.html
12. The Complete REACH documentation. http://europa.eu.int/comm/enterprise/reach/overview.htm
13. Timelines on REACH
14. Small Business Europe “Issue tracker: Chemicals (REACH)”. http://www.smallbusinesseurope.org
15. BASF 2004 REACH analysis
“The Interim Strategy” http://ecb.jrc.it/REACH/content1.php
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