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30 May 2018

REACH after 10 years: state of play after registration deadline

The European Regulation on chemicals (REACH) is based on the ‘no data, no market’ principle. Manufacturers and importers of chemical substances had a period of 10 years to register their products with the European Chemicals Agency (ECHA). That period ended on 31 May. Tony Musu, an ETUI expert on chemical risks, takes stock of the situation.

The period for registering chemical substances laid down in the REACH Regulation closed on 31 May. From now on, substances that have not been registered will not be allowed access to the European market. What is your assessment at the end of this important phase?

Tony Musu: There is no doubt that the system works because more than 21 000 substances produced in or imported into Europe in quantities of more than one tonne per year have been registered over the last 10 years. This number is a little lower than expected but is impressive nonetheless. Importers and manufacturers have got on board.

What has been less successful is the updating of the registration dossiers, the first of which, covering volumes of more than 1 000 tonnes per year and carcinogenic, mutagenic and reprotoxic substances, were established a decade ago. It has become clear that once the dossiers are registered with the European Chemicals Agency (ECHA), very few companies update them, despite this being important to ensure safe use of the substances.

REACH seems to have worked relatively well from a technical perspective. Is the same true for the actual prevention of chemical risks in companies?

T.M.: This question goes back to the problem of insufficient updating of the registration dossiers and the quality of the data they contain. Unfortunately, it is not always possible to rely on the data in the dossiers to guarantee safe use of the registered substances. Everything that follows is influenced by these dossiers, especially the quality of the safety data sheets: there are many more pages now than there were 10 years ago, because information has been added on all uses of the substances and they have also become more complex. There is still a great deal of work to be done by employers, who are required to ensure that their workers know how to understand and use the safety data sheets. It is this training that needs to be improved not the simplification of the safety data sheets, a frequent complaint by employers. The ECHA will have to encourage companies to update their dossiers and will have to be much, much stricter when it comes to low-quality dossiers. It should use the stick more often than the carrot to encourage manufacturers to respect the ‘no data, no market’ principle. Withdrawing a company’s registration number [needed to access the market] if a dossier is not in conformity would be one very effective measure.

The Regulation does not contain any specific provisions on nanomaterials. Does it need to be updated to ensure better protection for consumers and workers from this emerging risk?

T.M.: Although the annexes to the Regulation will soon be amended, REACH is indeed relatively weak when it comes to identifying risks linked to nanomaterials, and the same goes for endocrine disruptors. More generally, a criticism that can be made of REACH is that it does not yet allow for the identification of new substances of very high concern, once again because of the failure of companies to update their dossiers, the highly variable quality of the data provided and the fact that many companies make use of opportunities to avoid certain tests on animals.

Alongside the ‘registration’ phase, which has just closed, REACH also has an ‘authorisation’ requirement for substances that are of very high concern because, for example, they cause cancer or genetic mutations or because they are harmful to reproductive health. Has this mechanism already helped to clean up the European chemicals market?

T.M.: This question requires a nuanced response. Yes, the system for candidate listing substances awaiting authorisation, which acts as a ‘waiting room’ before they are possibly moved to the authorisation list, is a very powerful tool that encourages users of substances of very high concern to stop using them in favour of safer substances.

Unfortunately, it has become clear that once substances are on the authorisation list, the famous Annex XIV, authorisations are nearly automatically granted. The legislator has therefore favoured the market with the justification that if companies put so much effort in to obtain authorisation it is because they really need it. A system that works is one that refuses authorisation if it is unwarranted. One example of this, which has been written about extensively, is the authorisation of lead chromate paint to mark ground surfaces, particularly roads. This use was approved even though safer alternatives existed. This is clearly one of the aspects of the REACH system that will have to be improved in the years to come. The ECHA could do a great deal more to improve the incentives for companies to use alternatives to substances of very high concern.

The controversies over glyphosate and endocrine disruptors highlight the growing concerns of the public about the effects of chemicals on human health and the environment. Has REACH helped to raise awareness in this regard?

T.M.: REACH actually gives consumers the right to information. The famous Article 33 gives consumers the right to ask articles manufacturers if their products contains substances of very high concern. One of the lessons from 10 years of REACH is that Article 33 is extremely underused, to the extent that environmental NGOs have developed smartphone apps [1] that allow you to scan the barcode of a product and find out if it contains any substances of very high concern. Initiatives like these need to be built on in the future because consumers clearly want to move towards products that are better for their health and for the environment.

Alongside REACH, which relates to the internal market, there is other European legislation, in the social field, that ensures protection for workers from chemical substances, especially carcinogenic substances. How do these laws interact?

T.M.: These two pieces of legislation are actually supposed to support one another in order to improve prevention from chemical risks in the workplace. The REACH Regulation is an ‘elephant’ compared to the legislation on workers and it became evident that it was encroaching on the latter. For example, occupational exposure limit values (OELs) were imposed for certain substances in REACH, despite the fact that this is really the role of the legislation on the protection of workers. One example of this is NMP [N-methyl-2-pyrrolidone], a solvent frequently used in industry. Under the influence of REACH, the task of defining OELs increasingly tends to fall to the ECHA, even though it was previously the role of a committee of experts from the Commission’s DG Employment [Scientific Committee on Occupational Exposure Limits, SCOEL]. It is by no means certain that the ECHA experts have all of the necessary skills to deal with exposure in the workplace, especially when the risks are not linked to marketed chemical substances but to the substances generated by certain processes, which is the case for diesel engine emissions or the crystalline silica that is produced when stones are ground. The Commission has not yet determined whether the SCOEL or the ECHA’s committee of experts [Risk Assessment Committee, RAC] will be responsible for proposing OELs. A possible solution seems to be to incorporate some of the SCOEL experts into the RAC, which would preserve the SCOEL’s expertise on workplaces and provide the ECHA with additional personnel.

During the arduous negotiations that preceded the adoption of REACH, manufacturers predicted that it would be a disaster for the European chemicals industry, and jobs in particular. These predictions did not come true…

T.M.: The predicted apocalypse has not materialised, there have been no large-scale relocations, and the European chemicals industry has continued to make profit, despite a slight slowing-down because of the 2007-2008 crisis and competition from Asian chemicals companies.

Interview by Denis Grégoire, ETUI

[1] ToxFox and Scan4Chem. Another project, AskREACH, is currently being developed.

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