Chemical substances are being increasingly used in different sectors, including the pharmaceutical one. Thousands of these chemical substances have still not been regulated for, thus no specific Occupational Exposure Limits (OEL) have been established for them.
Of all the chemical substances currently in use, the OEL has only been established for about a thousand. The process involved in establishing it requires a considerable amount of resources given that all the toxicological and epidemiological studies have to be carried out to obtain the pertinent values.
The value most often used in the chemical-pharmaceutical industry to define a specific exposure limit for operators is the aforementioned Occupational Exposure Limit (OEL). In general, the establishing of in-house exposure limits involves a complex process because the classifying of substance into a particular category is not a mathematical exercise, but rather involves the evaluation of all the available scientific information. To this end, toxicology uses different sources such as toxicological databases, epidemiological, in silico studies, etc.
Occupational exposure limit values are a useful tool, along with others, to assess the risk and make decisions about the prevention measures of certain harmful effects for health involved in handling chemical substances. Based on our experience, we offer a series of posts in which we propose an occupational exposure evaluation strategy that will help us to choose the appropriate technical and organisational measures to control the risk.
What regulation rules the occupational exposure in Europe?
Under Article 3 of Directive 98/24/EC on risks related to chemical agents at work and Article 4 of Framework Directive 89/391/EEC employers are legally obliged to organise a work place that does not endanger the health of their employees. Article 3 of Directive 98/24/EC establishes the binding occupational exposure limit values as well as the EU-wide biological limit values. For any chemical agent that has an occupational exposure limit fixed at EU level, Member States must establish a national occupational limit value, bearing in mind the one set by the EU. Article 5 of Directive 80/1107/EEC, amended by Article 6 of Council Directive 88/642/EEC on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work introduced the aim of establishing occupational exposure limits into EU legislation.
In fine, the use of chemical studies in industry is increasing worldwide. Thousands of these chemical substances still have no specific occupational exposure limits. Therefore, strategies need to be established to define the occupation exposure levels related to the handling of chemical substances. Moreover, this is an ethical responsibility and obligation provided for in the Occupational Health and Safety regulation.
We at Azierta have an expert toxicology team (AETOX, EUROTOX and ERT accredited) in determining occupational exposure limits and in APIs Categorization, which associates the exposure limits with specific safety measures (engineering control, standardised work processes and safety equipment). Our multi-discipline Occupational Health and Safety team has the expertise, moreover, to design complete health vigilance protocols to ensure safe work environments.
If you wish to learn more about this aspect of our work, visit Azierta: OEL and API Categorisation and follow us on our social networks
Mar Crespo and Gastón Ariel Estruch, (Operations Manager en Gentec Pharmaceutical Group- Div. Pharmanoid)