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Topic: REACH & CHEMICAL SAFETY

Impact of the New REACH Law

March 27, 2009

We don’t usually discuss European chemical safety laws. But when those laws stretch across the Atlantic and have a direct impact on companies in the U.S. and Canada, they become an important topic of conversation for SafetyXChange. Enter REACH—arguably one of the most significant imports from Europe since, I don’t know, the Yugo.

What Is REACH

REACH stands for the Registration, Evaluation, Authorization and restriction of Chemicals. Chemical safety regulation in Europe is nothing new. But REACH ties all the national rules into a unified regulatory system.

The goal of REACH is to control the manufacture and distribution of chemicals that can harm human health and the environment. Instead of creating an army of government enforcers, REACH relies on industry to police itself. The foundation of the system is the requirement that manufacturers and importers of chemicals register their substances with the European Union Chemical Agency (EUCA) to provide a basic data base that downstream users must access to minimize the dangers associated with their own uses. Chemicals that cause high concern will have to be authorized by the EUCA.

REACH Registration

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REACH registration requirements apply to about 30,000 substances manufactured, imported, used as intermediates or placed on the market in the EU (there are exemptions, e.g., for radioactive substances and waste chemicals). Thus, manufacturers and importers from outside Europe including, of course, Canada and the U.S., will have to negotiate the REACH registration process to do business in Europe.

Manufacturers and importers must submit a technical dossier to the EUCA containing technical information about each substance manufactured or imported in quantities of one ton or more per year. If annual manufacture or import is 10 tons or more, the company must also submit a detailed chemical safety report. The detail of information required for registration increases for manufacture or import of 10 to 100 tons and gets cranked up another notch for 100 tons or more. Exemptions:

  • Substances that are already adequately regulated, such as medicines;
  • Substances that pose low risk, such as oxygen, certain noble gases and cellulose pulp; and
  • Minerals, ores, ore concentrates and other substances occurring in nature, as long as they’re not modified.

Implementation of REACH

REACH took effect on June 1, 2007. The first phase of the REACH system, pre-registration, ended in December. Now full blown registration is underway. Registration deadlines vary depending on the kind of substance involved:

Date Action
1 December 2008 Registration for existing substances (that have not been pre-registered) starts
1 January 2009 List of pre-registered substances published
1 June 2009 First recommendation of priority substances to be considered for authorization published by ECHA
1 December 2010
PHASE 1
By this date the following pre-registered ‘phase-in’ substances must be registered when supplied at:

  • ≥ 1000 tons per annum (tpa) or;
  • ≥ 100 tpa and classified under CHIP as very toxic to aquatic organisms or;
  • ≥ 1 tpa and classified under CHIP as Cat 1 or 2 carcinogens, mutagens or reproductive toxicants
1 June 2013
PHASE 2
Deadline for registration of substances supplied at ≥ 100 tpa
1 June 2018
PHASE 3
Deadline for registration of substances supplied at ≥ 1 tpa

What to Do About REACH

As downstream users, U.S. and Canadian companies may be caught up in the REACH registration net. The first thing companies need to do is take inventory of their chemical products, including the chemical composition of finished products and determine which, if any, of these substances require REACH registration.

REACH compliance will place a burden on IT systems. It will require consolidation of information from different systems and the integration of new information. You’ll also have to obtain data from your suppliers. In addition, downstream users will need data from you so they can comply. There are a number of commercial REACH software or web-based management products on the market that you might want to consider using.

Conclusion

If you manufacture or import chemicals that are used in Europe, you better be on top of REACH. Registration isn’t an easy or quick process. And the longer you put off dealing with REACH registration, the greater your chances of being shut out of European markets.

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