Enhesa - Global EHS & Product Compliance Assurance

How to avoid hearing the phrase “you should have known” in 2022


Courtesy of Courtesy of Enhesa - Global EHS & Product Compliance Assurance

On 4 June 2012 a silent revolution happened, and it went unnoticed by many of us. In Europe, the number of chemicals in use classified as carcinogens quadrupled. If you are a Corporate Director or Manager you should have concern regarding the implications of this in the long run, as it is one of the few issues that may find you on trial for willfully neglecting EHS regulations in the workplace. We all know about the numerous asbestos cases which have pushed companies into bankruptcy and sentenced Directors to jail time. Twenty years after the fact, it’s easy to question why those companies and directors didn’t take appropriate action. Today, 2000 chemicals have been added to the list of 600 chemicals that cannot be present at your workplace. Ten years from now, it’s likely that we’ll see another wave of Directors in the courtroom, claiming no knowledge of the issue and receiving the simple reply, “you should have known,” from the judge.

Any employer in Europe has the obligation to avoid the use and exposure of workers to carcinogens. It is the only issue that has had a substitution obligation in the law for almost 20 years. If you are still using a chemical classified as a carcinogen, you will need to research and document that there is NO alternative available and that exposure CANNOT be prevented. Economic considerations are not an excuse in this regard. If it turns out that there is an alternative and that there is a way to prevent exposure, it should be implemented immediately. Furthermore, it is not enough to do this assessment once – you will need to make sure that the assessment is updated in function of the latest developments, and this has to happen annually at a minimum. Failure to document that you have done everything that could be done may sentence you to jail in 10, 20 or 30 years.

This subject was amply illustrated by the Eternit asbestos court ruling in Milan (Italy) in February 2012. Compared to the asbestos issues in the eighties, it will be much easier to prove that you have used a chemical classified as a carcinogen. Data on the chemicals in the supply chain and the use of chemicals at your facilities are being documented and collected from numerous angles. This will make things much easier in ten years from now to identify who is to blame, especially if the use of a particular chemical caused an exceptional increase in the number of former employees who are now battling cancer.

The silent revolution is one of the outcomes of the European REACH regulation, which obliges manufacturers and distributors to test chemicals and report the results, and the European CLP Regulation, which obliges the manufacturers and distributors to notify chemical classifications.

Although the issue is driven by European Regulations, you should be under no illusion that you’re “safe” if you don’t have facilities in Europe. Most governments tend to follow the thought leaders on the issue and, if need be, a prosecutor will use general obligations against you.

The International Agency for Research on Cancer (IARC) was established in France in 1965, but it was California that first regulated the issue with Proposition 65 in 1986. The European Union followed hesitantly with a Directive on the issue in 1990, but they had to wait until 1996 to get the first dozen chemicals identified as carcinogens. Since then, the list has grown almost exponentially to over 1000 chemicals in 2012. Only 600 of these seem to be commercially available and appear in the REACH registrations or CLP notifications up until now. More frightening is the fact that the chemical industry has identified and reported an additional 2000 substances as Carcinogenic, Mutagenic or Toxic for Reproduction under either REACH registration or the CLP notification process.

What should you do to stay away from accusations in 2022?

First and foremost, you must ensure that you have no chemicals classified as carcinogens, mutagens or toxins being used for reproduction. However, this is easier said than done, as most chemical inventories will look at raw materials purchased and often use a classification based on Annex VI of the European CLP Regulation (former Annex I of the Directive 67/548/EEC). Thus, you will need to make sure that:

  1. your inventory covers all chemicals purchased (including for example cleaning or maintenance products classified as hazardous chemicals)
  2. the use of the chemical or product is in line with the intended use described in the Material Safety Data Sheet. If this is not the case, you either need to change the supplier or the product, or get an MSDS which mentions your use. This is the only way you can ensure that your MSDS provides the proper information in terms of chemical releases and precautions to be taken during use. It’s also quite obvious that you need to follow the precautions provided by the supplier.
  3. your inventory is kept up to date on the basis of the classification in the material safety data sheets provided by your suppliers. It is clear now that the chemical testing imposed by REACH is identifying chemicals that were not known to be carcinogenic until now. Your supplier will want to avoid his liability, and inform you of this with a revised MSDS as soon as he becomes aware of this.
  4. the classifications in your MSDS are not below those that have been set by the Regulations.
  5. you eliminate any chemical classified as a carcinogen and any process leading to exposure to a carcinogen.
  6. you take the appropriate corrective measures as soon as you become aware of a change in classification.

These six steps may appear easy on paper, but are often difficult to implement in practice. Make sure that you have the proper policies, corporate standards, procedures and instructions in writing, to avoid any confusion. Lastly, don’t forget to call us if you need assistance.

About enhesa
Enhesa is a global environmental, health and safety consultancy, providing EHS regulatory compliance assurance support to industry worldwide. Having to identify, understand and assure compliance with a multitude of legal requirements is a fact of doing business in today's global marketplace. Having said that, we realise that this is often easier said than done, which is where we come into the picture. Enhesa has been helping business and industry ensure ongoing compliance for years, and we have developed a range of products and services tailor-made to the needs of our clients. Wherever your business is located, Enhesa's team of highly trained and experienced, multilingual consultants is in a unique position to keep you ahead of the latest regulatory and policy issues as they unfold.

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