INSIGHT: Reach process like D-Day without bullets

31 January 2007 17:12  [Source: ICIS news]

By Joe Kamalick

 

FORT LAUDERDALE, Florida (ICIS news)--The massive organisational undertaking required of EU and US companies to meet fast-approaching deadlines of the EU programme for registration, evaluation and authorisation of chemicals (Reach) may be likened to D-Day without bullets - but there will be casualties nonetheless.

 

Long a matter of legislative debate, denunciation and delay, Reach is now law and, to the surprise of many, it will force tough decisions by thousands of companies in little more than 18 months.

 

To be sure, final actions by EU regulators on the fate of tens of thousands of substances and chemicals will drag on into the next decade, but the first crucial regulatory deadline affecting existing chemical products is June 2008.

 

Meeting that deadline for pre-registration of existing products will, in the words of one US chemical trade official, “have profound effect on the significant US-EU trade in chemicals and products that include chemicals”.

 

“It will require a lot of effort by a great many companies throughout Europe and in the US,” said Steven Russell, senior director for health, products and science policy at the American Chemistry Council.

 

Indeed, Russell and many others believe that June 2008 and other subsequent Reach compliance deadlines perhaps cannot be met. “Is it do-able?” Russell put the rhetorical question at the council’s two-day Reach compliance conference earlier this week. 

 

“We’ll have to wait and see.”

 

While Reach was given final EU approval only in December last year, it sets a breathtakingly brisk pace for its first compliance deadlines.

 

Depending on their volume of production and use, perhaps as many as 100,000 existing chemicals and substances will be subject to Reach evaluation and authorisation - and restriction for many - in phases over the next dozen years.

 

However, to qualify for that extended phase-in evaluation process, existing chemicals and substances must be pre-registered during a six-month window of 1 June to 1 December 2008. Failure to pre-register a chemical product during that six-month period will result in loss of phase-in status. In addition, the Reach rules apparently deny continued production or import of chemicals and substances that are not pre-registered.

 

So if a chemical product is not pre-registered with the EU by December next year, it and goods containing it will, with few exceptions, be barred from the European market. In other words, game over. Blacklist.

 

Under Reach each chemical product or substance will be given one registration, and multiple producers of the same substances are already forming what Reach calls substance information exchange forums (SIEFs). These groups will facilitate registration by compiling existing information, conducting studies and resolving chemical classifications.

 

It will require extraordinary co-operation among competing producers, and they will have to be scrupulously careful to avoid anti-trust complications in the process.

 

Not all the information required for the long-term registration process need be completed for pre-registration. For pre-registration only the name of the substance, its chemical abstract and European inventory numbers and production volume range are required.

 

However, the effort to co-ordinate those requirements among thousands of producers for tens of thousands of products and substances will be Herculean to say the least.

 

That combined with the long-term costs and effort required for Reach registration and evaluation may, Russell said, move firms to forego pre-registration for some of their products. 

 

This is where casualties occur. 

By the time the pre-registration period begins in mid-2008, Russell said, “a lot of companies will have to make a lot of decisions”. Among them, he said, will be decisions on which products to continue manufacturing. 

“If a given company is manufacturing, say, six chemicals in the same product family,” he said, “that company might decide to cut its lines back to five or four in order to reduce its registration costs”.

Robert Matthews, a Washington, DC attorney who specialises in Reach requirements and compliance for US firms, says the pre-registration process is “the most critical aspect of Reach”.

 

“One goal and intent of Reach is to ultimately remove from the marketplace what Reach regulators will determine are substances of very high concern (SVHC),” Matthews said. 

 

“But an unintended consequence will be that the high cost and effort required of companies to successfully register their chemical products under Reach will outweigh the profit potential for some substances that otherwise do not pose an environmental risk.”

By: Joe Kamalick
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