The second registration deadline of REACH has expired. It's time to look to the future, says Dr Dieter Reiml.
So far, for many of the chemicals currently on the market, there is no precise information about their potential risks and hazards. Since the EU REACH regulation, manufacturers and importers have a duty to determine these potential hazards and to have the relevant substance registered.
The regulation has affected around 60,000 chemicals since REACH came into force in 2007. Following a successful pre-registration phase, a second registration deadline just expired at the end of May 2013. The third deadline expires in 2018 and will affect mainly small and medium-sized enterprises (SME). Since the requirements of REACH are extensive and can tie up critical capacities particularly for SMEs, the advice of the REACH experts at TÜV SÜD is to become pro-active at an early stage.
REACH shifts the responsibility for safe handling of chemical substances to manufacturers, importers and downstream users and resellers. The demands on enterprises from all industries are enormous - in respect of both technical requirements and timely registration as well as business and organisational challenges.
The new regulations are complex and extensive. The aim is even better protection for employees, customers and the environment. The first registration deadline for chemical substances which are marketed in large quantities expired at the end of 2010. Almost 4,900 different substances were recorded in about 28,000 dossiers across the EU.
At least as many substances again should have been registered by 31 May. This time the focus was on average substance quantities (100-1,000 metric tons per year). The remaining smaller quantities of chemical substances above 1 metric ton per year must then be registered by mid-2018.
Chemical substances that have not been registered may no longer be manufactured, imported or placed on the market within the European Union after each deadline expires. Apart from a few exceptions, the registration requirement applies to substances above 1 metric ton per year which are produced in the EU or are imported into the EU. Further requirements arise depending, for example, on classification. In the case of hazardous substances, it is a requirement for the supplier to submit a safety data sheet which must also take the substance's use into account. It should contain a safety assessment and suggested risk reduction measures. Reliable information transfer within the supply chain - from manufacturer or importer via reseller to user - is also important. This is the only way in which the registration can allow for all types of use.
REACH presents small and medium-sized enterprises with special challenges for two reasons. Firstly, if certain substances are manufactured or imported in lower tonnage bands, it is often not known whether the quantity threshold of 1t/a will actually be exceeded or even whether the relevant substance will still be marketed in 2018. Secondly, many SMEs do not always have adequate staff resources to deal intensively enough with REACH. This results in typical registration errors with the risk that the company will have to stop manufacturing or trading in the relevant substance. The meaningful and forward-looking construction of the REACH requirements can often be critical to the existence of SMEs.
Although the registration requirement for smaller substance quantities above 1metricton per year does not end until 2018, this deadline affects small and medium-sized enterprises (SMEs) in particular. It is specifically here, however, that implementation of the extensive regulations can be time-consuming. The obligations and consequences are not always obvious at first glance and the level of complexity is often underestimated. The experts at TÜV SÜD with their decades of experience recommend that those responsible for registration by 2018 should address the problem now so that they do not get behind schedule.
TÜV SÜD's medium-sized enterprises initiative, as a REACH service specifically for SMEs, will ensure reasonably-priced, timely and successful registration of chemical substances. SMEs are usually co-registrants. TÜV SÜD supports submission of the registration dossier for these co-registrants. There is no need to learn IUCLID and REACH-IT, for example, nor to constantly maintain and update these IT systems. This simplifies the overall process and the enterprise can concentrate on its core competencies.
Dr. Dieter Reiml TÜV SÜD Industrie Service GmbH, Munich, Germany. www.tuev-sued.de/is