HOUSTON – REACH (registration, evaluation and authorization of chemicals) legislation that went into force June 1 in Europe requires knowledge of the entire life cycle of a substance, a European Union oil industry association official said at the NPRA International Lubricants & Waxes meeting last week. Chemical manufacturers and importers must be ready to act fast, to meet the narrow preregistration window from June to December next year.
You can no longer produce a substance, throw it on the market, and forget about it, said Lothar Kistenbruegger, technical director for CONCAWE (Conservation of Clean Air and Water in Europe). You will have to know what happens to the substance. Regulatory obligations under REACH rest primarily with manufacturers and downstream users, rather than distributors, he said.
While pre-registration is an obligation of the manufacturer, he said, there are certain situations where downstream users must do so. He said the downstream user needs to inform their supplier of their uses associated with the substance. If the user doesnt want to disclose a use, which is quite common, then the downstream user will have to register that use separately, he said.
Kistenbruegger emphasized that REACH affects both manufacturers and importers of substances. If you sell an additives package to a European lubricants manufacturer, then this lubricants manufacturer in Europe will have to register every single component of the additives package, Kistenbruegger said.
CONCAWE, based in Belgium, was established in 1963 by a small group of leading oil companies to carry out research on environmental issues relevant to the oil industry. Its membership has broadened to include most oil companies operating in Europe. CONCAWEs activities focus on environmental, health and safety issues.
Membership in CONCAWE has almost doubled since December 2006, according to Kistenbruegger. It was very clear to the refiners that it was going to be difficult to comply with the regulations under REACH, he said. Almost 100 percent of the refining capacity in Europe is applying for membership.
On June 1, 2008, REACH preregistration for existing substances starts, with a phase-in approach. Registration for new substance, without a phase-in, also begins. On Dec. 1, 2008, registration begins for existing substances that have not been preregistered.
Registration is in three phases: June 2008 to November 2010 for high-volume or high hazard chemicals; November 2010 to June 2013 for moderate-volume chemicals; and June 2013 to June 2018 for lowest-volume chemicals.
Kistenbruegger said REACHs approach is mainly based on risk management over the complete life cycle of a substance.
CONCAWE is conducting a risk assessment of petroleum substances, including development of risk assessment methodologies. The risk assessments will form the basis for preparation of registration dossiers required under REACH. The association anticipates offering the registration dossiers via licensing agreements to nonmembers or importers who will also face the obligation to register petroleum substances under REACH. Kistenbruegger said CONCAWE has also established a REACH help desk at its Web site for those wanting to contact the association about related issues regarding petroleum substances.
In January 2009, a list of preregistered substances for REACH will be published and Substance Information Exchange Forums (SIEFs) will be formed by potential registrants to ensure that one substance is registered with one dossier and that animal test data will be shared.
He said one regulatory affairs issue concerns the strategic business decision of who registers a companys substances for REACH. All your customers are separate, he said. An alternative for some companies will be to set up a legal entity within the European Union to register for all of its customers in Europe, Kistenbruegger suggested.
He emphasized the importance of knowing the preregistration deadlines and registering.
If you fail to register your substance, youre not going to be allowed to put your substance on the market, Kistenbruegger said. It is indeed something thats going to affect your business.