By Bernard D. Silverstein, CIH – an EES Associate
The overall aims of a new chemical strategy proposed by the European Commission (EC) 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. Seven objectives that needed to be balanced within the overall framework of sustainable development were:
Protection of human health and the environment
Maintenance and enhancement of the competitiveness of the EU chemical industry
Prevention of fragmentation of the internal market
Increased transparency
Integration with international efforts
Promotion of non-animal testing
Conformity with EU international obligations under the WTO.
The EC believes that the REACH achieves all of these objectives. REACH (Registration, Evaluation and Authorization of CHemicals); will eventually affect manufacturers or importers of more than one ton of chemical products per year. These companies would be required to register their products with a newly established EC agency. The aims of the regulation are to improve the protection of human health and the environment while maintaining competitiveness and innovation in the chemicals industry. REACH will require the chemical industry to manage the risks from their products and to provide and share safety information. This information would be passed down the chain of production to all identified users and to share health, safety and environmental information with other manufacturers and importers of the same products or chemicals.
THE REACH SYSTEM
The regulation would replace over 40 existing directives and regulations. REACH would require companies that produce and import chemicals to assess the risks arising from their use and to take the necessary measures to manage any risk they identify. This would reverse the burden of proof from public authorities to industry for ensuring the safety of chemicals on the market.
Registration: This is the main element of REACH. Chemicals that were manufactured or imported in quantities of more than one ton per year and per manufacturer/importer would be registered in a central database. Some groups of substances would not have to be registered (such as certain intermediates, polymers and some chemicals managed under other EU legislation). The registration would include information on properties, uses and safe ways of handling the chemicals. The information required would be proportional to production volumes and the risks that a substance poses. The safety information will be passed down the supply chain, so that those that use chemicals in their own production processes – to produce other products – could do so in a safe and responsible manner, without jeopardizing the health of workers and consumers and risking damage to the environment.
A new European Chemicals Agency would manage the database, receive the registration dossiers, and be responsible for providing non-confidential information to the public.
Evaluation: There would be two types of evaluation, of dossiers and of substances.
A dossier evaluation would have to be carried out on all animal testing proposals. The main purpose of this compulsory evaluation is to minimize animal testing. REACH has been designed with the goal of restricting animal testing and costs to industry to the necessary minimum. It will require the sharing of testing data and encourages the use of alternative sources of information. Dossiers will be evaluated to check that the registration was in compliance with the registration requirements.
Secondly, European Chemicals Agency could evaluate any substance where they had justified reasons to suspect that there was a risk to human health or the environment. This would represent a quality and compliance check. For both types of evaluation, the outcome could be a request for further information.
Authorization: Substances of very high concern would require authorizations for use. Substances of very high concern include Carcinogens, Mutagens and Reproductive toxins (CMRs), Persistent, Bio-accumulative and Toxic Chemicals (PBTs), Very Persistent and Very Bio-accumulative Chemicals (vPvBs) and substances identified as having serious and irreversible effects to humans and the environment equivalent to these categories. If the risks from the use of such a substance could be adequately controlled, authorization would be granted. If they could not be adequately controlled, the Commission would evaluate the risks and benefits to society and decide whether the substance would be authorized.
COSTS and BENEFITS of REACH
By closing the knowledge gap for more than 30,000 existing substances it will provide information on both their acute and long-term effects. For industry, there will be higher demand for safer substances which will boost innovation while REACH gives more flexibility for chemicals undergoing research and development. The total costs to the chemical industry and its downstream users are between 3 and 6 billion dollars.