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EU chemicals legislation : helping SMEs Published on: 04/11/2013, Last update: 27/11/2013

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Undoubtedly, the EU chemicals legislation brings benefits for society.

But there are gains for industry, too. Companies have developed a clearer insight into their product portfolios and addressed more systematically the hazards of the industrial chemicals that they place on the market. By identifying their uses, they have helped establish a better picture of the risks that merit dedicated risk management measures. Such stewardship contributes to the protection of human health and of the environment. It also helps identify potential for innovation.

Yet, the regulatory burden has its costs. Companies have needed to adapt their business and production practices. Establishing the data for dossier submissions and handling communication in the supply chain has its expense. Small and medium-sized enterprises are more limited in their means to bear as well as mitigate the effects of this burden. Some have little experience in handling their obligations under REACH or CLP. The new Biocidal Products' Regulation requires companies even with long practice in the field to acquaint themselves with a new IT tool and novel regulatory processes. SMEs are often formulators preparing for the 2015 CLP deadline for classifying mixtures. Many will also soon be setting out to register dossiers for phase-in substances by the 2018 REACH registration deadline.

To address the challenges ahead, the European Commission attached a specific SME Annex to its REACH Review published in February of this year, with about a dozen specific recommendations addressed to the Agency and to other actors. Over the summer months, ECHA has been looking for ways in which we can provide additional support for SMEs. These will go beyond the recommendations in the Commission's REACH Review. However, ECHA needs to act within its boundaries. The Agency is mandated to manage the implementation of the EU's chemicals safety legislation. It cannot grant SMEs any lenience regarding their legal obligations. SMEs are responsible for their share in ensuring the safe use of chemicals in Europe. Their compliance is imperative to manage the risks emanating from the daily use of chemicals in our modern industrialised societies. This may even result in some restructuring of the market.

Another constraint is that the voice of SMEs is difficult to hear. Small and medium-sized companies and their representatives often see the legislation, as such, as being burdensome, but may not be able to identify the support they might appreciate. To facilitate compliance, ECHA needs to be in a position to duly identify the real concerns and still unaddressed needs of SMEs, even if small and technical, in relation to ECHA's work and regulatory processes. The Agency should not be second-guessing these needs.

ECHA also wants to reach out to the companies that are not yet aware of their obligations under the EU chemicals legislation. Evidently, readers of this Newsletter do not belong to this group, but it would serve the Agency's aim if readers could encourage their business partners to subscribe to it and to ECHA's e-news to help us to make other companies aware of their responsibilities and opportunities.

ECHA is continuously refining and updating its IT tools, its guidance and its communications with stakeholders and with the general public as well as its support to duty holders. A large part of the body of ECHA's website, the ECHAterm terminology database and many guidance documents are available in 23 official EU languages. Practical Guides and User Manuals, numerous webinars, web-forms, publications, and other help are provided. Targeted events such as the annual ECHA Stakeholders' Day address many issues of interest to SMEs. The work laid out in the CSR/ES Roadmap that ECHA published on 17 July is relevant to facilitate communication in the supply chain. ECHA has recently updated the Navigator tool that allows duty holders to orient themselves on their obligations and published Guidance in a Nutshell on Registration.

ECHA is currently exploring further proposals and avenues to render its support more SME friendly. The Agency intends to simplify its communication and correspondence with duty holders, to involve SMEs in focus groups to help develop its IT tools and other services, to provide more predictability in its work and stability in its guidance whilst expanding the number of guidance documents in a nutshell, and much more. Evidently, the complexity of the EU chemicals safety regime and of its implementation sets limitations to any such simplification effort. On many issues, ECHA will need to closely cooperate with partner organisations, for instance through its networks of national helpdesks or Accredited Stakeholder Organisations. To address practical problems in handling substance information exchange forums, particularly with data sharing or the cost of letters of access, ECHA will contribute to a forthcoming SME workshop that the European Commission will be hosting from 10 to 11 December 2013 in Brussels. And, much else is ongoing. The ECHA Newsletter will regularly emphasise such activities.

As of this summer, I am involved in the Agency's effort to address the needs of SMEs, in the newly created function of an SME Ambassador.

I will interact with the various bodies at EU level that have a generic interest in SME issues, such as the European Union's SME Envoy network, formations of the European Parliament or the High Level Group on Administrative Burdens, and with associations representing SME interests. Within the Agency, my role is to raise awareness of SME concerns and act as a catalyst in introducing SME-focused considerations into the Agency's activities.

Andreas Herdina
ECHA Director of Cooperation