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European rules: nearly three years into the European Union's overhauled chemical regulations, some businesses are learning that the consequences for their bottom lines aren't all bad.

Sometimes the revamping of Europe's chemical regulations seems like a too-long soccer game. On one side is "Brussels," the code word for the bureaucracy of the European Union, which has developed standards in manufacturing that in many cases supersede those of the EU's constituent nations. On the other side are the local and national practices, many of them old and well established.

In 2007 the "Brussels" side scored the equivalent of a goal, in pushing through the harmonization of standards for the reporting of the environmental and human risks of chemicals used in the EU chemicals regulation known as REACH {Registration, Evaluation, Authorization and Restriction of Chemicals}. Three years later, this change continues to have ripple effects that are being felt across the Atlantic in Canada, by any company that exports or otherwise sells products in the EU. This is particularly true since, under REACH, members of the chemical sector are faced with a challenging, time-sensitive process that can add significantly to their costs and timelines if not carefully managed. On the other hand, with many large chemical companies now knee-deep in the process, the regulatory overhaul is proving to have some favourable side-effects for industry.

REACH is intended to provide enhanced protection to human health and the environment by making industry responsible for assessing and managing the risks posed by chemicals, and providing safety information to users along the supply chain. This means that all manufacturers and importers of chemicals in Europe must identify and manage risks linked to the substances they manufacture and market.

For substances manufactured or imported in quantities of one tonne or more per year per legal entity, manufacturers and importers need to demonstrate that they have appropriately identified and managed those risks by means of a registration dossier, which must be submitted to the European Chemicals Agency (ECHA). In parallel, the EU can take additional measures on highly dangerous substances, where there is a need for complementing action at the EU level.

This means that all suppliers to EU countries, including companies exporting to the EU, will have to provide documentation and support the European registrant on the effects of their products, in each use for which they are intended.

The REACH regulation, which came into force on June 1, 2007, involved a pre-registration deadline of December 1, 2008, which allowed companies some additional time to prepare the final registration dossier to be submitted before the deadline by which their product would need to be registered. Companies that missed that pre-registration deadline are now forced to submit a full dossier before they can continue their business in Europe.

In spite of the headaches for chemical producers, propitious possibilities in research and business have started to emerge. The roots of REACH go back to one of the principles of the EU--that standards should be harmonized across all constituent members rather than being set by each country, and that the standards chosen should be at least as stringent as the most stringent round in the Union.

In the case of chemicals, the "Eurocrats" in Brussels decided that the implementation of REACH was also an opportunity to incorporate some of the current understanding about toxicity and the need to protect the environment and human populations.

It is also a chance to develop an understanding of the effects of some chemicals whose effects were partly or completely unknown before. While the human toxicity of common chemicals is widely understood, the other environmental effects may be more of a mystery. For some of the more exotic or recently-developed products, little if any data exists, and so in requiring this type of testing, REACH is pushing the frontiers of human knowledge.

Information provided through REACH can be useful globally and in this way, is able to lift the entire world to a new level in managing the human and environmental side effects of our chemical-dependent lifestyle.

REACH pushes the envelope and develops new standards in other ways as well--such as in the measures taken to limit the amount of testing being done on animals. The REACH legislation stipulates that no toxicity testing on vertebrates should be duplicated, acknowledgement of growing public concern over unnecessary hardship for other living beings.

REACH also reaches into new territory through the development of a process in which normally-competing companies work together to pool their research. This means that they must overcome their natural suspicion of sharing data with any outside entity, let alone a direct competitor.

It also means dealing with any threats to the public interest that might arise if the competing companies were to suddenly become too-close friends, which could result in collusion on pricing or the creation of artificial shortages.

REACH allows for the formation of consortia, as formally established groups of companies that have pre-registered the same chemical substance. These consortia work tightly together towards the final registration and are also part of the whole group of pre-registrants, the so-called Substance Information Exchange Forum (SIEF, see sidebar). In this way, competing companies now work together with a joint registration as their goal.

For companies seeking a potentially lucrative new niche, REACH could prove to be a boon. Complying with REACH is not a short-term endeavour. Just as the situation on a soccer field is always changing, new products and new uses of existing products are always developing. This means that for companies exporting to the EU, becoming skilful at meeting REACH requirements is likely to become much like a soccer team's ability to move the ball down the field to the goal--an area of major competitive advantage.

DOING THE LEGWORK

by Stephen Goudey

It is important for chemical producers and importers to develop relationships with testing service providers to ensure compliance with OECD Good Laboratory Practices (GLP) and acceptance by regulators.

The wide range of biological, physical and chemical tests required may be beyond the abilities of any one facility, so laboratories have to form alliances in order to offer clients a full scope of testing services. The onus and liability are also on the producer/importer to ensure data quality and compliance--third party audits of testing facilities are strongly recommended.

While the European Chemicals Agency (ECHA) has stated its intention to minimize the amount of animal testing, companies may have to commission research with long testing periods, possibly involving multi generations of animals to comply with the data reporting requirements under REACH.

This means that one of the challenges facing companies seeking to comply with REACH will be finding laboratories with the capacity to do the required testing within the allotted timeframe. Accordingly, it is a good idea to book testing as soon as the information gaps for a given material are known.

ECHA recognizes the challenges posed by the testing timelines, and will accept some registration dossiers without the need for all testing to be completed.

One of the biggest challenges has to do with classification of engineered nanomaterials, where there is little to no environmental and human health-effects data and there are no established protocols for testing.

Stephen Goudey is president of HydroQual Laboratories Ltd. in Calgary, Alta.

LEARNING TO SHARE

As a general rule, every pre-registered phase-in substance has its own Substance Information Exchange Forum (SIEF). So, early in the REACH implementation process, companies that normally compete with each other joined forces to carry out research on the effects that their common substances have on the environment and on human health. In this way, groups of companies that have determined that they produce the same substance share the cost of research related to the effects of that particular substance. In most cases, the membership fees they pay to the SIEF are based on the tonnage per year they produce or import into the EU. Companies in the SIEF nominate one of their member companies as Lead Registrant, which will take responsibility for making sure that the research is done correctly, and which will submit the completed joint registration dossier. The Lead Registrant collects an administrative fee from the other SIEF members.

The SIEF is intended to facilitate data sharing for the purposes of registration, and for member companies to agree on the joint submission of data related to the Chemical Safety Assessment and the Chemical Safety Report as well as the classification and labelling of the substances concerned.

Within some SIEFs, member companies have formed several groups or consortia, sometimes because of the alliances and relationships among chemical producers.

For some substances there may be a SIEF group cooperating, but no Lead Registrant has stepped forward to take the wheel and start the registration work, with the challenging testing process. This can provide a big manufacturer an opportunity to make sure that the registration process is initiated. The companies sharing the work for a common registration may contribute with data they own and benefit from their past investments in testing the human health and environmental effects of a particular substance they manufacture.

Working within a SIEF requires a spirit of cooperation and trust. It starts with determining whether or hot all companies involved are actually producing the same substance, or if there is a need to establish another SIEF to deal with what may actually be two or more different products.

When a common product is recognized, SIEF members will pool the data that they already have on the product, determine where the information gaps are, and then develop a plan for closing those gaps.

Companies based outside of the EU cannot be SIEF members, as they cannot register a substance under REACH. However, they can work through the entity that imports their product into the EU or through a designated "Only Representative" that manages their obligations under REACH.

KB and TRS

KEEPING PACE

The chemical industry is working under an aggressive timeline to comply with REACH, with the next big deadline looming just a few months from now.

June 1, 2007: REACH entered into force.

June 1, 2008: Pre-registration for existing substances started. These substances will be phased in. Registration for new substances also began on this day.

November 30, 2008: This was the deadline for pre-registration of existing substances.

December 1, 2008: This was the deadline for registration of existing substances that hadn't been pre-registered.

January 1, 2009: The European Chemicals Agency (ECHA) published their first recommendation of priority substances to be considered for authorisation.

YOU ARE HERE

November 30, 2010: This is the deadline to submit a registration dossier to ECHA for existing substances imported in quantities of 1,000 tons or more per year as well as for existing substances classified as carcinogenic, mutagenic or toxic to reproduction and imported in quantities reaching 1 ton or more per year and for existing substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment and imported in quantities reaching 100 tons or more per year.

May 31, 2013: This is the deadline to submit a registration dossier to ECHA for existing substances manufactured or imported in quantities of 100 tons or more per year.

May 31, 2018: This is the deadline to submit a registration dossier to ECHA for existing substances imported in quantities of 1 ton or more per year.

Kenneth Bergroth heads the REACH compliance initiative of the global environmental consulting firm Golder Associates, and is based in the company's Helsinki office (where ECHA is also based). Contact: + 358 50 559 5596; kenneth_bergroth@ golder.fi. Theresa Repaso-Subang is a board-certified toxicologist in the Mississauga, Ont. office of Golder Associates Ltd. Contact: 1-905-567-4444; theresa_repaso-subang@golder.com

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Title Annotation:INDUSTRY: REGULATIONS
Comment:European rules: nearly three years into the European Union's overhauled chemical regulations, some businesses are learning that the consequences for their bottom lines aren't all bad.(INDUSTRY: REGULATIONS)
Author:Bergroth, Kenneth; Repaso-Subang, Theresa
Publication:Canadian Chemical News
Geographic Code:4E
Date:Mar 1, 2010
Words:1938
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