Harmonisation of chemical legislation

Publish date: March 4, 2005

Written by: Gunnar Grini

The three-year-old REACH proposal, designed to improve European information on, and protection from, harmful chemicals represents a giant step towards increased control and regulation on substances with harmful effects on human health and the environment.

Current European Union (EU) legislation for chemical substances is a patchwork of many different directives and regulations which developed over time. Existing legislation does not require the provision of sufficient information about the effects of the majority of existing chemicals on human health and the environment and does not oblige manufacturers and industrial users of new chemicals to provide information regarding possible health and environmental effects.

The Registration, Evaluation, and Authorisation of Chemicals (REACH) system was proposed by the EU Commission on October 29th 2003. The two most important aims of this system are to enhance the competitiveness of the EU chemicals industry and to improve protection of human health and the environment from the risks of chemicals.

The proposed REACH regulation will harmonise the legislation on both new and existing chemicals for the entire EU and place the responsibility of providing information for health and environmental effects on the industry itself. REACH has the potential to push European industry towards sustainability. In the long term, REACH will also increase the competitiveness of the chemical industry because it provides European producers and manufacturers with incentives to develop cost-efficient ways of meeting future environmental legislation.

Inclusion of intermediates and radioactive substances
There is no doubt that REACH represents a giant step towards greater control of the use of harmful chemicals. So far, the initiative does not include substances used as intermediates in production, despite the fact that some of the highest concentrations of harmful chemicals are found at production facilities.

High concentrations of harmful substances in production facilities might cause severe health damages for workers with daily exposure. It is therefore important that the REACH regulation includes intermediates and imposes the same requirements on the producers and importers as those governing chemicals used in products.

The same principle holds for radioactive substances, which so far have been defined as outside the scope of REACH. Radioactive substances obviously have harmful effects on human health and the environment, but traditionally these have not been regulated in the same legislation as other chemicals. The implementation of REACH is a golden opportunity to change this, and impose on the producers and users of such substances to provide information on the properties and risks of using radioactive substances in production. In a harmonised chemical legislation, it is only fair that radioactive substances are controlled by the same demands imposed on other chemicals.

Bellona has argued for the development of a plan for phasing in radioactive substances into the language of the REACH regulation. The inclusion of radioactive substances should take place within five years from the start of the REACH registration.

Volume or risk; an either or question?
There is an ongoing debate in the EU over whether harmful chemicals should be phased into the REACH regulation based on volume produced or on the risk of harmful effects on health and the environment. The argument from the industry is that it would be wise to prioritise the most dangerous chemicals first, which would also lighten the administrative burden on the industry. However, the health and environmental effects of many chemicals, and especially of old substances, are not, or only poorly, known.

A system only based on risk might exclude chemicals that are produced in great amounts and have lesser known impacts on health and the environment. It is therefore important that the Commission not veer from its approach wherein the time schedule for the phase-in of the substances is decided depending on volume manufactured.

There are cases where a substance used in large amounts is proven to be harmless to human health and the environment. In this case, such a substance should not need to undergo the full registration procedure. This could help to alleviate the heavy administrative burden on the industry, which could dull their competitive edge against competitors in other parts of the world. This might be especially helpful for small down-stream users.

The Bellona Foundation suggests the obligatory performance of a risk assessment by certain pre-determined criteria. This should be used to decide whether a substance could be considered harmless and placed in Annexes II and III of the REACH proposal, which exempts certain substances and materials from registration. This approach will also clarify the criteria that apply for the chemicals to be listed in the annexes.