The European chemicals regulation REACh - the registration, evaluation, authorization and restriction of chemicals - not only aims to improve the protection of human health and the environment. Put into force in 2007, it also aims to enhance innovation and competitiveness of the EU chemicals industry. Eleven years into REACh and with the last registration deadline of 31 May, 2018, but also the Brexit on the horizon, the European Commission has recently published the results of the second review of REACh. Michael Reubold asked Erwin Annys, REACh director of the European Chemical Industry Council CEFIC, about the status quo and the future of chemicals regulation in Europe.

CHEManager: Mr. Annys, a bit more than a decade since the launch of REACh, the final registration deadline is looming on the horizon for Europe’s chemical companies. From June 1, 2018, only substances that have a valid registration – or are exempted from REACh – will be allowed on the EU market. Do you fear any substance shortages?

Erwin Annys: The message sent by our companies and national chemical industry associations are clear: they are working hard to get the job done in time, but they feel comfortable that the substances they want to keep on the market and those they are purchasing to make their products will be registered in time. As chemical industry we feel comfortable that we will make it. The predicted number of substances for the 2010 and 2013 deadline turned out to be fairly accurate, but the number of substances that will be registered by May 2018 will probably deviate from the 2003 estimates.

Downstream users are more concerned as they don’t always know which substances are used in the mixtures they import. They are much more uncertain and don’t have the confirmation that all mixtures and substances will still be on the market. This uncertainty is probably related as well to the fact that many substances and mixtures are imported from outside the EU and they fear last minute announcements that the imports will stop because foreign producers are not able to comply with REACh.

May 31 – the point of no return – is that it? Or do you expect ECHA to allow any extension period? What happens, for instance, if registration dossiers have been submitted but are incomplete?

E. Annys: There is no possibility to extend the deadline for the last registration deadline, and an extension will not solve the problem. Uncertainty in the supply chain as to whether particular imported substances will still be on the market will persist.

It is important to realize that these issues are discussed in the so called Directors’ Contact Group, consisting of ECHA, The European Commission and European industry associations covering all concerned sectors. Just as in 2010 and 2013, the group is developing recommendations on how to handle last minute surprises and how to act in case substances and mixtures are no longer available.

What advice do you have today – if it is not too late – to help companies register successfully?

E. Annys: For 2018 registrants - concentrate on the work to be done: register. And for importers, list the substances and mixtures for which you don’t have a confirmation yet and contact your suppliers to get the latest update. If they tell you now that it will not be available anymore, you still have time to change supplier or register as an importer yourself.

What happens after successfully registering all substances affected by REACh? Can manufacturers and their customers lean back then?

E. Annys: It has always been clear but is now even clearer after the publication of the REACh Review [by the European Commission on 5 March, 2018] that May 2018 is absolutely not the end of the journey. The evaluation of existing dossiers and regulatory risk management will continue as the Commission wants improve the implementation. The focus on improving supply chain communication and communication on articles is also clearly mentioned in the REACh Review, which is closely linked to the alignment between REACh and Circular Economy Action Plan, where this kind of communication will become more important

How is REACh affecting chemical innovation? Is there a risk that manufacturers develop new substances which could be prohibited in certain applications?

E. Annys: The legislation is clear on what are substances of very high concern, although you can never be 100% sure. Many innovative companies are using predictive methods - like QSARs and the CEFIC LRI Ambit project - to have a good idea about potential toxicity and eco-toxicity. Hence a general prohibition is less likely, but in certain application is possible. Industry has realized as well that the time needed for a harmonized classification or for identification as SVHC is clearly shorter compared to the past, which makes the early screening even more necessary.

Looking past REACh, how can Europe’s legislative framework for chemical management be strengthened over the coming decades?

E. Annys: This will be done via a continued improved implementation of REACh, going hand in hand with enforcement. Many of the issues already covered by REACh are as well repeated and further explored under the 7^th Environmental Action Programme. The REACh Review, and we expect even more of it in the Fitness check on chemicals legislation excluding REACh, will lead to a more holistic approach to chemicals legislation in the European Union. The interactions between the various legislative frameworks will augment and the REACh information will be used for decision making in other Regulations and Directives related to chemicals.

As chemical industry, we believe that this should happen in a transparent way giving the industry an opportunity to contribute as this is done under REACh. A major challenge will be the evolution of science, covering much more complex endpoints then under the previous legislations. Therefore, we will need much more joint scientific events involving industry, academia and authorities and integrate the results of this collaboration into regulatory risk management.

The 2018 registration deadline of REACh is not the only incision or caesura looming for Europe. The Brexit is also on the horizon. How can REACh be implemented into UK law? Will the copy-and-paste approach do?

E. Annys: CEFIC is in favor of the highest regulatory consistency between the EU and the UK after Brexit or the UK establishing its own regulatory regime similar to REACh, if they are not joining the REACh world. In fact the potential problems are not limited to REACh, but we have to find solutions as well for plant protection products, biocides, pharmaceuticals etc. CEFIC supports an approach of grandfathering, allowing a continued use of already registered substances without restrictive actions. What has been approved before Brexit via registrations and authorizations - depending on the specific terminology of the different legislations - should freely remain on the UK and EU market after Brexit. It is important to realize that a hard Brexit will not only have serious consequences for the UK, but also companies in EU Member States who have actively trade with the UK-based companies.

How do you see the future of REACh – or chemicals policy and trade in Europe – in a post-Brexit world?

E. Annys: The future of chemicals policy in the EU is already quite well fixed in the REACh Review and the Fitness checks and that will not be influenced by Brexit. The UK authorities and their agencies are presently very active in the EU decision making regarding chemicals. However, the EU negotiating guidelines for the future trade relationship with the UK exclude UK participation in EU agencies. This would mean that other authorities will have to take up that additional work and that will be very challenging, also in view of the Commission willing to further speed up. UK companies exporting to the EU obviously would need to meet REACh requirements.