Safety studies on the risks of chemicals will benefit everyone

Chemical safety has recently aroused a lot of debate. It is alarming that the effects of many chemicals on health and the environment are not yet known. The European Union has taken up this problem, and the objective of the current chemicals policy is to assess the risks of all existing and new chemicals, which would shift more of the responsibility for products safety to manufacturers. Tero Karhi reports.

Today, modern society is dependent on a large number of different chemicals that are used, for example, in pharmaceutical, textile, automotive and foodstuffs industries. The gross production of chemicals has grown substantially, and the present production figure is as high as 400 million tonnes. About 100000 different existing substances have been registered in the EU markets, and the total value of chemical industry in the world in 1998 was about E1244 billion.

At the moment, the European Union is the biggest chemical industry producer, and the United States is number two. At a general level it can be said that chemical industry is a significant branch of manufacturing industry that employs a large number of people and enables the operation of other industrial sectors by producing chemicals for use in the manufacture of a multitude of products.

Chemicals also create many problems, and hence it is essential to know their properties and adverse effects on health and the environment. Recently, some diseases have become more common at an accelerating pace. For instance, allergies, asthma and testicular cancer in young men have increased, and the pathogenic effect of some chemicals has been thought to be one reason for these. There has been uneasiness about the effects of many chemicals on health and the environment. Hence it is understandable that consumers also fear the problems created by chemicals in the environment and in their own well-being.

Responsibility shifted to producers

More of the responsibility for chemical safety has been shifted to manufacturers by authorities' decisions. The producers must study the safety of the substances they use. The level of studies is directly dependent on the production volumes. The EU's White Paper deals with the European Union's chemicals policy, and its objective is the safety of both the environment and consumers.

In the White Paper, the system of industrial chemicals classifies aexisting substances' and anew substances' separately. The existing substances are the ones reported to have been launched by September 1981, while new substances have entered the market thereafter. The number of new substances is around 2700, and according to the EU directive the health and environmental risks caused by them must be researched and assessed. Researching of existing substances is also demanded, because there is not yet sufficient knowledge about their properties and purpose of use. Implementation of the document would require re-assessment of the safety of more than 30000 chemicals on the market before the year 2012.

Especially drugs and many other biotechnology products contain chemicals with high safety requirements. Drugs are expected to have the desired effect on symptoms. Foodstuffs also contain large amounts of different chemicals, and hence safety and knowledge of the risks are demanded. These are substances that enter the human body.

Behaviour in different conditions

The study of chemical safety must be carried out in many different ways in order to learn about their behaviour in different conditions and in different purposes of use. On the basis of the studies, it should be possible to anticipate the different applications in which the chemical might appear. For instance, there must be advance knowledge about the effects of skin cream if by mistake taken internally, and, similarly, the effects of a new substance on skin must be known. New areas of application for chemicals may be found by accident. In those cases the safety of the chemical must be assessed and possibly re-researched in this specific area of application. For instance, a substance that is found as oxidation inhibitor in glues is also used as a general anaesthetic. New inventions are continuously being made, and consequently, research must be carried out all the time, and risks have to be mapped according to the situation. Especially in drug development the product development phase may take more than ten years, and the safety of the product must be precisely studied, before human body is exposed to a foreign substance.

At the moment, instructions for the study of foodstuffs are the only ones that are still defective. The EU is, however, preparing such instructions, because there is a definite need for them. The consumers are very concerned about the safety of foodstuffs, and unawareness adds to suspicion. Better access to knowledge will improve the consumers' awareness, which in turn will force the industry and the authorities to take more responsibility for the environmental and health effects of products. On the other hand, knowledge dispels fears and doubts, and therefore increases safety.

Results through planning

Researching chemical safety is a kind of process. It starts out from a strategic plan that estimates the future application and target group. Additionally, the existing authorities' regulations on different chemicals, both new and existing ones, are mapped at this phase. On the basis of the known properties of a substance, it is possible to define in advance the so-called hot spots where risks can probably be expected.

After the strategic plan has been completed, the research starts with cell cultures, screenings and acute, short-term animal tests which provide preliminary results. On the basis of these results it is possible to proceed to the next phase in which the vital functions system of the research subject is specified or the exposure becomes long-term. Special tests are conducted to study, for example, certain vital functions, such as operation of the heart and circulatory system and the central nervous system.

At this phase, when the above mentioned tests have been completed, the safety of the product can be assessed on the basis of the risks found and the amount used. After the risk assessment, it is also possible to make risk management plans in order to minimise any harm. Irrespective of whether the product has been found safe or containing certain risks, the research can be extended to mechanical toxicology, ie the operating mechanisms of the product's side effects can be studied. When the side effects of the products are better known, the risks can be better managed by drawing up useful instructions, eg for storage and transportation.

In a safety survey the risks of chemicals are sought in all means possible. The researchers must be able to suspect and question the safety of the product. They must also know how to seek risks in unexpected items. Safety research requires special expertise, and there are companies that focus on providing these services for industry. These companies have gathered together the required knowledge, skills, facilities and equipment. Safety research requires lots of experience in the industry itself, as well as academic knowledge. Furthermore, there is need for pure technical know-how, because laboratory work is still largely manual.

The relationship of a safety research service company to its clients has to be based on trust and co-operation. Indeed, the service provider needs to achieve trust by convincing the client with its competence and opportunities, and the best results are reached through seamless, long-term co-operation between the producer and the research laboratory. Today, the fact that safe products are everybody's benefit has been well adopted. Safe products benefit both the research units, producers, supervising authorities and end product users, and, of course, the environment.

Enquiry No 15

Tero Karhi is with SafetyCity, Turku, Finland.

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