REACH deadline looming

September 16, 2010
Stephanie Sutton
Pharmaceutical Technology Europe

The European Commission has issued a last call for REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) registration; an EU initiative targeting companies that import or produce chemicals, which will ultimately impact a number of industries, including pharmaceuticals.

The European Commission (EC) has issued a last call for REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) registration; a European Union (EU) initiative targeting companies that import or produce chemicals, which will ultimately impact a number of industries, including pharmaceuticals. The deadline for registration of the most widely used or most dangerous chemicals is 30 November this year.

In a memo, the EC reminded users of chemicals (which includes pharma companies) that they will also be affected by REACH because they depend on the availability of substances on the market. Any non-registered substances manufactured or placed on the market after the November deadline will be illegal. The registration process will also generate manufacturers and importers’ recommendations for the safe use of chemical substances, which will be passed on in the supply chain.

“Our chemical industry needs to be sustainable. Therefore, we appeal to all companies concerned to submit their dossiers in time and in full,” Antonio Tajani and Janez Potočnik from the EC explained in a statement. “These demands on companies are tough but they are also an investment that will pay off by fostering the leading role of Europe’s chemical industry.”

According to the EC, one of the main reasons for developing and adopting REACH is that there is insufficient information on a great number of chemicals, which are often imported into Europe in large amounts, and the hazards they pose to human health and the environment. “REACH aims to ensure that the risks from substances of very high concern are properly controlled, and to progressively replace these substances where there are suitable alternatives,” says the EC.

Companies submitting REACH dossiers have first had to gather data about the environmental and health properties of their chemical, and then share such data with other companies that produce or import the same substance using the Substance Information Exchange Fora (SIEFs). As of 10 September 2010, about 4000 dossiers had been submitted to the European Chemicals Agency, and the rate is increasingly very rapidly, according to the EC.

REACH came into force in June 2007 and the November deadline marks an important milestone in the phasing-in process. The upcoming deadline will apply for:

  • substances produced or imported in volumes of 1000 tonnes* per year or more
  • substances that are carcinogenic, mutagenic or toxic to reproduction and produced or imported in volumes of 1 tonne per year or more
  • substances that are very toxic to the aquatic environment and produced or imported in volumes of 100 tonnes per year or more.

For other substances, the deadlines for registration are 2013 and 2018. More information about this is available on the ECHA website.

*Note: 1 tonne is equal to a metric ton, or 2205 lb.