Last reviewed 3 August 2020
Caroline Raine discusses how companies can keep up to date with chemical regulations and the impacts that are specific to the chemicals used within their business.
Over the last fifteen years there have been so many changes to the way that chemicals are regulated. In December 2006 the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation was published. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. All of the registration deadlines have since passed, but REACH does not stop there, the chemicals are being continually assessed and reviewed and it is possible that they will be further regulated, restricted or even banned. But how do companies keep up to date, how do they know what is coming and what has been decided, and more importantly how do they get some notice?
The first and perhaps easiest approach a company can take is to join a trade association or subscribe to a software package or chemical legislation tracker. That way the hard work is done for you. Although this isn’t always the cheapest option, and it is possible that not all of your chemicals are tracked and covered. So, there is definitely room for something to slip through the net.
The best approach is for the company to appoint someone either internally or externally to track the regulations and/or the status of chemicals. This is often a regulatory compliance manager or health and safety manager when internally and externally is often an independent consultant.
For those tasked with the job of tracking chemicals and compliance there are many sources of information available.
The Croner-i database is an excellent source of information. The topics outline the legal requirements with some great workflows that ask pertinent questions to help to understand your legal requirements. Articles and questions and answers are written on key hot topics. And the database contains over 100, 000 substances and dangerous goods showing not only their physical, chemical and environmental properties but also their regulatory status.
As well as providing the wealth of information already discussed, the Croner-i Hazardous Substances Database also provides useful information on substances that may have further restrictions. The database shows whether the substance is a Substance of Very High Concern (SVHC), on the authorisation or candidate list and if the substance is subject to a restriction under REACH. Links are provided to substances that have been registered with ECHA.
For each substance where it is available the IUPAC name, CAS number and EC number are shown. Synonyms for each substance are listed and the structure and molecular and/or structural formula is provided.
The database was recently updated to include the Simplified Molecular-Input Line-Entry System or SMILES for substances, along with the IUPAC International Chemical Identifiers Std.InChI and Std.InChIKey.
It is a great source of information!
ECHA website – EUCLEF
The European Chemicals Agency (ECHA) released its new database, the EU Chemicals Legislation Finder (EUCLEF) in March 2020. It allows companies to look at the legislation that applies to a particular substance. There are approximately 40 pieces of EU chemicals legislation in the database and there are plans to expand that with a further 16 pieces of legislation are planned to be added to EUCLEF in 2021. For each piece of legislation detail is provided on the scope of the regulations, the obligations, exemptions, regulatory activities and lists of impacted substances. Links to all of the full legal texts in all EU languages are also provided.
The intention is to give businesses a better understanding of the obligations they might have so they can ensure they are legally on the market.
ECHA has many lists that can be monitored for current or future obligations or restrictions.
The Candidate List of substances of very high concern (svhcs) for Authorisation.
The authorisation list — those substances determined by ECHA for replacement by a less hazardous substance.
Public activities coordination tool (PACT) provides an overview of the substance-specific activities that authorities are working on under REACH and the CLP Regulation.
Registry of SVHC intentions until outcome this list aims to make interested parties aware of the substances for which an SVHC dossier is planned to be submitted to ECHA.
Community rolling action plan (CoRAP) Substance evaluation. If a substance is on this list, it means that a Member State has evaluated or will evaluate it over the coming years.
The Regulation on the classification, labelling and packaging of substances and mixtures (CLP) is often updated through Adaptation to Technical Progress (ATP). These ATPs are released as and when required and can often result in a change of classification.
Rather than waiting till the ATP is published, those substances under consideration for a change in classification always have a consultation. It is worth while monitoring these too, they can be found on ECHA’s website Harmonised classification and labelling targeted consultations.
Chemical regulations are fast changing; the intention is to protect human health and the environment and so many chemicals are being restricted, authorised, evaluated. It can be hard to keep up and is most definitely a full-time job!
It is very important to keep up to date and monitor, because if you don’t and your chemical is banned you might not have the time available to use a less hazardous chemical. Research and development can take years so the more notice you have the better. Classification changes can result in change to safety data sheets and labels. A product that you sell may have previously been non-hazardous may now be classified. This might result in research and development to reduce the amount of the substance in your product or it may require more customer communications to reassure the end buyer.
Of course, we have only scraped the surface in this article. There are many other requirements and potential changes, poison centres notifications, substances of concern in products (SCIP), polymers, nanomaterials, endocrine disruptors to just mention a few!
Buying yourself and your company as much time as possible is key — and can only be successfully done by keeping up to date with consultations and the status of lists.