ECHA

Half a century ago, the EU established the Directive on Dangerous Substances, planting the seeds from which the system for classifying, labelling and packaging of chemicals in Europe has steadily grown. We spoke to Gunilla Ericsson and Henk Roelfzema, two experts with decades of experience working on classification, to find out what we have learnt and how the history impacts today’s chemical safety.

Gunilla Ericsson. Image: ECHA.

With a heightened public awareness about hazardous substances in the 1950s, for instance, due to controversies surrounding thalidomide and asbestos, the need to control them began to emerge.

In the EU, this was done 50 years ago with the introduction of the Dangerous Substances Directive in 1967. The aim was to harmonise the individual laws governing the classification, labelling and packaging of dangerous substances in each Member State.

 

Handling substances in the right way

One important aspect of the directive was to go further than identifying hazards – one main goal was to actually communicate them to workers and consumers through the labels on the products, and also specifically to workers and their employers through the safety data sheets.

Henk Roelfzema. Image: Henk Roelfzema.

“The directive reinforced that users have the right to know about the chemicals they are dealing with and how they can safely handle them. This may sound self-evident now, but it was a new feature when the directive was introduced,” says Ms Ericsson from ECHA’s Classification and Prioritisation Unit.

The directive introduced danger symbols, standardised phrases defining the hazards of dangerous substances and preparations, as well as safety advice.

It also outlined how the appropriate standard phrases had to appear on the packaging and labels of products and on the safety data sheets.

To help reduce risks that could arise from using hazardous substances, users also need to know why their substances have a certain hazard.

“It was not enough just to tell users to wear protective gloves. It had to be justified and made clear to them so they could understand why they should do so, for instance, by explaining that the substance is corrosive and, if not used properly, can severely damage their skin,” Ms Ericsson elaborates.

In addition to increasing the information and awareness of the properties of hazardous substances and introducing first-level advice, through the labelling, on how they should be handled safely, classification has also had a major impact on how hazardous substances are regulated under other EU legislation.

Many other pieces of legislation set requirements to ensure that limit the possibility of using certain substances based on their hazard classification.

Examples include:

• REACH;
• regulations related to biocides and pesticides;
• regulations on the working environment and controlling environmental emissions; and
• regulations controlling the safety of substances used in toys, cosmetics and waste.

Steady progress

From its inception to its replacement by the CLP Regulation in 2008, the directive was regularly updated taking the latest scientific and technical progress into account. Each progression aimed to better protect human health and the environment.

As more hazard classes were gradually added, more substances benefitted from EU harmonised and legally binding classification and labelling.

“Initially, the directive classified substances on the basis of their physicochemical and toxicological properties such as toxic, harmful, corrosive and irritating. In later amendments, more endpoints were covered, more categories were added and criteria were extended to introduce ecological and carcinogenic, mutagenic and reprotoxic properties,” says Dr Roelfzema, toxicologist and former senior policy officer for CLP, cosmetics, consumer products and food packaging at the Dutch Ministry of Health, Welfare and Sport.

A pre-market testing system for new chemicals marketed in the EU was introduced in 1979. This was soon followed by the European Inventory of Existing Commercial Chemical Substances (EINECS), which listed all chemicals on the market before 18 September 1981.

Then in the 1990s, the Dangerous Preparations Directive was formed and became the legal foundation for classifying and labelling mixtures, introducing very similar rules for preparations as those contained in the Dangerous Substances Directive for substances.

“The introduction of criteria for aquatic hazards to the environment was also a milestone in the 1990s, as well as the widening of the scope of the toxicological assessment that was carried out. Where previously mostly teratogenic effects that cause malformations were classified, the scope was widened to also cover other forms of developmental toxicity, such as reduced foetal growth, and functional defects observed after birth,” Ms Ericsson adds.

Throughout all of these progressive changes, the focus was on relentlessly pursuing a solid understanding of the hazardous properties of substances and mixtures present on the EU market.

 

Classifying CMR substances

“Our main focus has always been on classifying substances that cause cancer, mutagenicity and effects on reproduction because these are severe effects on humans that may show up years after exposure has occurred and very often need a complex weight-of-evidence assessment. Already at an early stage of the directive, we knew there would be a need to concentrate on such substances,” Ms Ericsson tells.

So, experts focused on probable CMRs and a working group was formed under the Commission’s Joint Research Centre. Both Ms Ericsson and Dr Roelfzema were members of this group representing their respective Member States - Sweden and the Netherlands.

Candidate CMR substances were sent to this group so that they could provide advice on how these should be classified.

“Classifying CMRs has always been difficult. The three CMR categories are far too limited given the wide range of properties of the substances. Therefore, it requires the use of weight-of-evidence approaches and expert judgement to develop commonly-agreed views," Dr Roelfzema explains.

"Still, borderline cases develop and the challenge of these cases still exists. It is the role of scientists to raise attention to these cases and try to resolve any uncertainties about the classification of a substance. While the classification is hazard-based, a policy-based decision in borderline cases may be taken where a common opinion on the classification cannot be reached," he continues.

Improved transparency and increased integrity of experts

The process of classifying chemicals at EU level is more transparent than ever before. “If you want to see the underlying basis for why a substance is classified in a certain way, this is now much more visible than in the past as the opinions and all background information are available from the Committee for Risk Assessment’s (RAC) pages on ECHA’s website,” Ms Ericsson says.

Under the previous directive, the experts of the working group represented their respective Member States. However, this is no longer the case under the CLP Regulation.

The experts who participate in RAC are appointed as independent experts even though they are nominated by the Member States. This ensures the integrity of the RAC experts.

“It is safe to say that the experience that we obtained in Europe with implementing the Dangerous Substances Directive was crucial for forming the recommendations of the United Nations’ Globally Harmonised System. This in turn provided the genesis of the CLP Regulation and the backbone for how we classify and label chemicals in Europe today,” Ms Ericsson states.

“The work is, however, not finished and there is still a long way to go before we can talk about the worldwide harmonised classification of substances,” Dr Roelfzema concludes.
 

Did you know?   ECHA continuously screens what happens to the CMRs in the List of Harmonised Classification and Labelling for certain hazardous substances (Annex VI to CLP). Of almost 1 200 CMR substances on the list, about two-thirds are not registered, i.e. they are no longer on the market in significant quantities. This suggests that harmonised classification and labelling has been a driver for substitution.

 

European Commission's Regulatory Fitness and Performance Programme (REFIT)   As part of the European Commission’s Regulatory Fitness and Performance Programme (REFIT), a consultant study has been looking at the CLP Regulation and how it interfaces with other legislation. The work is ongoing but the general findings have shown that industry, Member State authorities and civil society stakeholders consider CLP to be an easier system to implement than the previous Dangerous Substances Directive.

 

Glossary   Dangerous Substances Directive (DSD) – relevant for the classification of substances until 1 June 2015. Substances classified as hazardous were labelled with pictograms that had an orange background. Dangerous Preparations Directive (DPD) – legal foundation for the classification of mixtures since 1988 and applied to mixtures until 1 June 2015. Mixtures classified as hazardous were also labelled with pictograms with an orange background. Classification, Labelling and Packaging (CLP) Regulation – European implementation of the United Nations’ Globally Harmonised System. With CLP, the pictograms with an orange background were replaced by diamond-shaped pictograms with a red frame. Globally Harmonised System (GHS) – classification and labelling system of the United Nations. The worldwide standard for classifying substances and mixtures. The GHS criteria for classification of substances for most hazards are very similar to criteria under the DSD. GHS is implemented in CLP and thereby applies within the EU.

Further information:

Understanding CLP

Classification of substances and mixtures

Labelling and packaging

Harmonised classification and labelling

The Directive on Dangerous Substances

Committee for Risk Assessment

RAC opinions on harmonised classification and labelling

CMR Report

Progressing together to identify substances of concern

 

Interview by Paul Trouth

Published on: 16 November 2017

Top image: © ECHA

If you liked this article, you may also like: REACH and CLP, what's working, what's not?, Newsletter 3/2016 So much information, so little space, Newsletter 4/2015