As an integral part of everyday life, chemicals are closely monitored to ensure they do not pose unacceptable risks to human health or the environment. Although regulatory measures are effective in ensuring safety, some of these measures overlap, creating burdens for companies and hurdles for industrial growth. The European Commission aims to take a coherent legislative approach to promote synergy in handling chemical risks.
Since the early days of the internal market, European legislation has regulated chemicals by setting common rules for safety and transparency. But as the production, distribution and application of chemicals continues to evolve, so, too, must the regulatory framework which ensures the appropriate identification and risk management of substances.
Currently, REACH (Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals) is the cornerstone of European chemical safety legislation. Adopted in 2006, REACH requires companies manufacturing chemical substances in the EU, as well as those importing into the EU, to register these substances with the European Chemicals Agency (ECHA). As a result, the uses and properties of nearly 6 600 chemical substances have been registered with the ECHA – part of the reason that 61 % of Europeans think chemicals are safer now than a decade ago.
In 2012, an evaluation of REACH confirmed that it delivers on all objectives. However, the evaluation also identified instances of overlap between REACH and other EU legislation affecting the use of chemicals.
Overlaps, generally, are regarded as situations in which multiple pieces of legislation may impose restrictions on the same substance, potentially leading to legal uncertainty. This could happen, for example, by imposing the same or similar regulatory requirements twice, or imposing conflicting requirements on the same actors according to two different pieces of legislation.
Aware of the burden this places on companies, the European Commission will examine how to eliminate or minimise duplications and inconsistencies between REACH and a range of other legislation. The EC has also organised workshops and discussions with regulatory actors at national and EU level to devise a coherent legislative approach for such overlapping cases.
REACH introduces a new mechanism for controlling the risk of chemicals: the authorisation of substances of very high concern (SVHC), which are identified by being listed on the so-called ‘Candidate List’.
From an industry perspective, coherence and predictability in the management of chemical risks by regulatory authorities are crucial. However, some stakeholders – particularly SMEs from manufacturing industries other than the chemicals industry – have difficulty understanding the process for identifying a substance as an SVHC under REACH.
Building on the experience gained in the identification of SVHC, European Commission Vice-President Tajani and the EU Commissioner for the Environment, Janez Potočnik, recently published the ‘SVHC Roadmap’, which will act as a guide for identifying all the relevant SVHC and listing them in the Candidate List by 2020. In addition to setting clear milestones and clarifying the division of responsibility between the European Commission, Member States and ECHA to place all relevant known SVHC on the list by the 2020 target, the Roadmap also helps companies to better understand the SVHC identification process. Enhanced communication between stakeholders during all phases of the process will lead to the most appropriate risk management measure.
While there are numerous instances of legislative overlap, phthalates, which are substances added to plastics to increase their flexibility and durability, are a prime example. REACH restricts the presence of certain phthalates in toys and childcare products, and also requires manufacturers and users of certain phthalates to obtain an authorisation in order to use those substances. However, the Food Contact Material legislation and the General Product Safety Directive are additional pieces of EU legislation addressing the risks of phthalates in other consumer products. Because phthalates are used in a variety of applications, from pharmaceuticals to glue, this overlap may create confusion and hamper multiple industries.
‘The European Commission is committed to addressing chemical risks in order to achieve a high level of protection for the European environment and its citizens while avoiding unnecessary regulatory burden for companies.’
European Commission Vice-President Antonio Tajani
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