Roadmap to REACH 2018

Helsinki, Finland – The European Chemicals Agency (ECHA) held its 10th Stakeholders’ Day at its headquarters in central Helsinki, Finland on May 27.

This annual event offers participants the chance to hear the latest news from ECHA about the REACH chemical regulatory process as well as receiving updates from European industry associations and NGOs. The event also took place in conjunction with the annual Helsinki Chemicals Forum (held on May 28 and 29).

This year over 200 delegates gathered in Helsinki. They were from 16 countries and represented 150 companies and 10 trade associations. Many more people were following the meeting online, participating in the Q&A sessions.

The three main themes of the Stakeholders’ Day included the REACH 2018 regulatory deadline; improving the quality of chemical substance dossiers; and risk management.

Copies of the presentations and extracts from the sessions can be found on the ECHA website.

REACH is a European Union directive concerning the registration, evaluation, authorization and restriction of chemicals. It came into force in June 2007 and replaced a number of European directives and regulations with a single system.

The administrative agency implementing REACH is the European Chemicals Agency (ECHA).

REACH has several key aims, which include:

• providing a high level of protection of human health and the environment from the use of chemicals;
• making the people who place chemicals on the market (manufacturers and importers) responsible for understanding and managing the risks associated with their use;
• allowing the free movement of substances within the EU market;
• enhancing innovation in and the competitiveness of the EU chemicals industry; and
• promoting the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across assessment frameworks (RAAFs).

The upcoming May 28 2018 REACH deadline means that all companies will have to register chemical substances that are manufactured within the European Union or are imported from outside the EU where volumes are above 1 tonne. This is the last major deadline for chemical registration which was outlined in the REACH Directive.

In addition to REACH, another key issue affecting the chemical sector relates to the European Union regulations on the classification, labelling and packaging (CLP) of substances and mixtures. The main CLP directive entered into force in January 2009.

Big numbers

On Stakeholders’ Day, senior managers from ECHA stressed that the REACH process so far has generated an enormous number of chemical registrations by companies working both within and outside the European Union member states.

Christel Musset, ECHA’s director of registration, noted that the REACH deadlines in 2010 and 2013 (covering larger tonnages of chemical substances) led to approximately 48,500 chemical registrations – including 2,309 for new substances and 12,900 for unique substances. There have also been 2 million study summaries; 6 million classification and labelling notifications for over 110,000 substances, plus risk management documentation.

REACH 2018 registration deadline

It is anticipated that the 2018 REACH regulatory deadline will create a significant increase in the submission of chemical substance information (up to 300% more chemical dossiers than were submitted to meet the 2010 deadline).

As the 2018 REACH deadline covers relatively small tonnages there will also be a significant increase in the number of small medium-sized enterprises (SMEs) being involved in the regulatory process. These companies will find the process far more expensive and time-consuming compared to the larger chemical corporations.

Many SMEs lack the necessary expertise regarding use of the REACH IT software and the collection of the required data. As a result many of these companies will have to join forces with other SMEs to form Substance Information Exchange Fora (SIEFs). The work of a SIEF leads to one joint submission for each substance, therefore reducing costs and avoiding unnecessary animal testing. The potential challenges of running a SIEF were discussed during the Stakeholders’ Day.

ECHA have upgraded their website and produced a range of new materials to assist registrants working to meet the 2018 deadline. The key IT software required by all registrants is also being upgraded – IUCLID Version 6 and REACH-IT software will be available during 2016.

During the Stakeholders’ Day, ECHA staff repeatedly stressed that information provided by registrants must be well-written, must avoid ambiguity, and must be complete.

A percentage of the dossiers will undergo detailed compliance checks by ECHA’s technical staff.  If they are found to be inadequate or badly prepared the registrants will find themselves in complex discussions with ECHA and may face sanctions if they fail to undertake remedial work.

ECHA officials say they expect to be answering many queries from companies in the lead-up to the 2018 deadline. They add that some companies, particularly SMEs, still do not appreciate that they are covered by the REACH regulatory requirements.

In order to increase awareness of the 2018 deadline, ECHA will be holding more webinars and information events, and publishing further factsheets and advice notes. ECHA have already indicated that the 11th Stakeholders’ Day will take place during 2016.

Reported by Andrew W. Cox, Energy Intelligence & Marketing Research. Andrew can be reached at andrew.coxuk@gmail.com.