The REACH Regulation is designed to deliver both a high level of protection from the potential risks posed by chemical substances and a strong, innovative European industry that is competitive on the global market. REACH concerns not only the traditional chemical industry, but also businesses from several other sectors. Relevant companies need to start working on registration now in order to meet the 1 June 2013 deadline. The European Commission and the European Chemicals Agency have developed tools to make sure that SMEs are well equipped and ready to fulfil their obligations.
REACH, which entered into force on 1 June 2007, is one of the most significant pieces of EU industrial legislation. Its main objectives are the protection of human health and the environment, enhancing competitiveness and innovation within the chemicals industry, and the free circulation of substances in the EU single market. Central to the legislation is the need to balance competitiveness and safety; in other words, ensuring industrial growth while keeping the environmental – and social - impact at a sustainable level. Minimising the burden on industry in meeting its REACH obligations also remains a priority of the European Commission.
The Regulation not only covers chemicals used in industrial processes, but it also extends to chemicals used in our daily lives, such as cleaning products, paints, furniture and electrical appliances. It recognises that the transition to a more sustainable, resource efficient and environmentally friendly economy is a challenging but necessary journey, and one in which new markets can be created. Indeed, industries that take into account the full environmental and economic impacts of their products and supply chain activities can help reduce the EU’s dependence on resources, promote innovation and make companies more competitive. This is at the heart of REACH.
Every industrial sector therefore needs to know about REACH. For instance, high levels of cadmium have been found in some jewellery articles, especially in imported imitation jewellery, and the European Commission has banned cadmium in all jewellery products, plastics and brazing sticks from December 2011.
The Regulation obliges all manufacturers and importers of chemicals to identify and manage risks linked to the substances they produce, import and market. Businesses need to demonstrate that they have done so appropriately by means of a registration dossier, which is submitted to the European Chemicals Agency (ECHA).
Policy makers have been careful to give industry enough time to meet their obligations. Recognising the large number of substances already in use, and the high number of companies making and/or importing them in the single market, REACH has established a ten-year 'phase-in period'. Companies that pre-register their substances can benefit from extended registration deadlines. Some of these dates have already passed (see box).
However, businesses must be aware of certain upcoming deadlines: by 1 June 2013, all substances manufactured and imported in quantities of more than 100 tonnes per year must be registered, while all substances manufactured and imported in amounts of more than 1 tonne per year must be registered by 1 June 2018.
It is vitally important that businesses prepare for these deadlines well ahead of time. Besides being complex and technical, REACH registration is also time consuming; preparing a dossier can take up to one and a half years, and the costs involved can be high. This is an issue not only for the chemical sector, but also for other sectors using chemicals.
For these reasons, the European Commission has taken special care to provide as much assistance as possible to businesses – and especially SMEs – to ensure that they are able to meet their obligations. For example, the European Commission has taken action to reduce fees for SMEs. These reductions amount to 90% for micro-enterprises, 60% for small companies and 30% for medium-sized companies.
European Commission Vice-President Antonio Tajani, Commissioner for Industry and Entrepreneurship, with the full agreement of Commissioner for Environment Janez Potocnik, said: “This has been a priority for me since the beginning of my mandate. Now with significant reductions of up to 90% for smaller companies in the chemical sector we will ensure that they continue to be competitive. With the REACH and CLP (Classification, Labelling and Packaging Regulation) regulations, we have laid the foundations for a modern legislative scheme, which also creates new opportunities for businesses."
To ensure eligibility for these reduced fees, businesses must determine their size based on staff headcount, annual turnover, and/or annual balance sheet total. While different definitions of SMEs exist in different countries, for the purposes of REACH, only the definitions set out in Commission Recommendation 2003/361/EC can be taken into account.
There is also a strong emphasis in REACH on the need to share data, in order to avoid repeating or duplicating work, limit testing on animals and of course in order to cut costs. For that registrants have to join a Substance Information Exchange Forum (SIEF), which brings together companies registering the same substance. Data sharing with other members of a SIEF is obligatory. Each SIEF nominates a Lead Registrant, who then submits the joint dossier to ECHA. Manufacturers and importers of substances in quantities below the threshold of 1 tonne per year and other stakeholders, who legitimately possess data on substances, can voluntarily join a SIEF and share data as data holders.
In addition, the European Commission and ECHA have developed a number of tools to help businesses – and SMEs in particular – conform to the obligations set out in REACH. SMEs not familiar with REACH can clarify their obligations by using the Navigator Tool, where they will also find Guidance Documents in 22 EU languages. Auto fill-in forms will enable SMEs to fill in REACH-IT web forms with one click. In addition, helpdesks in each Member State provide advice to industry on their obligations and how to fulfil these under REACH, in particular in relation to registration. European Commission Vice-President Antonio Tajani recently urged Member States to make sure that these helpdesks are appropriately staffed to meet increasing demands in view of the upcoming deadlines.
Most REACH measures have now been in operation since June 2008, replacing and amending previous legislation which left gaps in the safety assessment of chemical substances. In 2008, over 2.7 million pre-registrations were received by the European Chemicals Agency (ECHA).
By 30 November 2010, all substances manufactured and imported in quantities of more than 1 000 tonnes per year (but lower amounts for certain substances with a very specific classification, e.g. carcinogenic) had to be registered with ECHA. Around 25 000 registrations-dossiers for almost 4 500 substances were submitted.
Another major deadline fell on 3 January 2011, with the first notification deadline under the Regulation for classification and labelling. ECHA’s so-called classification and labelling inventory received some 3.1 million notifications for 107 067 substances.
Downstream users should take care that their substances are covered for all potential uses, and should communicate their uses to their suppliers by 31 May 2012 at the latest. The information communicated needs to be sufficient to allow suppliers to carry out an exposure assessment. Those using chemicals in high quantities can check ECHA’s website for information on registered substances and on those intended for registration in 2013.
It should be noted that other pieces of EU legislation have not been changed by REACH, and that companies should take care to ensure these obligations are also fulfilled.