ECHA

Welcome to our autumnal Newsletter. First of all, I would like to thank the 2 332 of you who responded to the feedback survey on our communications. We are looking at your feedback now and will publish it, with our proposed actions, as soon as we can. The actions I want to concentrate on should improve our customer service.

Registrations for substances manufactured or imported at or above 1 000 tonnes a year need to be updated with information about a second-species pre-natal development toxicity test (PNDT). This is a standard information requirement under REACH. Registrants whose dossiers are lacking this information should update them either with an adaptation statement or a testing proposal for second-species PNDT testing.

Correct substance identity matters for a successful REACH registration. It also enables the different REACH processes to function in a smooth and timely manner. What are the key issues when considering the identity of your substance and how can you describe your substance identity better?

To maximise the impact on the safe use of chemicals, ECHA is changing how it checks the compliance of registration dossiers. The aim is to identify substances of concern and coordinate different REACH and CLP measures to address these concerns effectively. ECHA's Management Board endorsed the new strategy in September and it will be implemented from 2015 onwards.

The German Federal Institute for Risk Assessment (BfR), with support from the Federal Environment Agency (UBA), is currently checking the data in REACH registration dossiers covering phase-in substances with a tonnage level equal to or above 1 000 tonnes per year.

REACH 2018 seems far away but companies need to start preparing now. The last registration deadline for existing chemicals, 31 May 2018, concerns substances manufactured or imported in low volumes, between 1-100 tonnes per year. This means that a larger proportion of small and medium-sized enterprises will be registering for the first time and large companies may well be registering hundreds of chemicals. Both groups face a considerable challenge. To support as far as we can, ECHA has created some new web content for REACH 2018.

Testing proposal examinations and compliance checks are evaluation activities done by ECHA but substance evaluation is the role of the Member States. In substance evaluation the focus is on the substance itself, and not on individual dossiers. The task is to find out if more information is needed to understand the potential risk of a substance to human health and the environment. ECHA Newsletter spoke with Member State representatives from Germany and France to learn about their experiences of evaluating substances.

One of the objectives of REACH is to increase and promote innovation among European companies. To help achieve this goal, the regulation includes measures to encourage and support innovation. In particular, substances that are only used for product and process orientated research and development (PPORD) can be exempted from the need to be registered.

There have been 25 applications submitted for authorisation to use substances of very high concern (SVHC) by about 40 applicants. So far, ECHA's Committees have issued opinions on three of those applications, for five uses. The European Commission has also published its first decision to grant authorisation in August 2014. Although the authorisation process is still quite new, things seem to be working as planned.

During the summer, ECHA launched a practical guide which gives advice to registrants on how to report information on intermediates in their registration dossiers. The guide also helps downstream users who need to provide information to their suppliers on intermediate uses of substances. The guide gives examples of the information that needs to be shown in intermediate dossiers.

On 16 September, the European Commission and ECHA held a workshop in Brussels to discuss the challenges faced by industry in complying with the requirements for the classification, labelling and packaging of mixtures. ECHA Newsletter met with two company representatives to get their perspective.

In June, ECHA published new web pages to help companies preparing for the 2015 mixture classification deadline. The pages were developed with the national CLP helpdesks. ECHA Newsletter spoke with Caroline Walsh from the Irish CLP helpdesk to hear how companies can best use them.

A little over a year has passed since the entry into operation of the Biocidal Products Regulation. The ECHA Helpdesk, however, started to offer support for companies with biocides questions in April 2013 and since then they have received over 1 300 enquiries. Find out what some of the most common questions are and where to find further information and support.

The Biocidal Products Regulation (BPR) enables companies to get authorisation for their biocidal products in all Member States with just one application. This ‘Union authorisation' allows companies to place their product on the entire European market without the need to apply for specific national authorisations. ECHA Newsletter spoke with Mr Ludger Grunwald, Director of Regulatory Affairs in Europe, Africa and the Middle East for Ecolab, a company that is preparing their first application for Union authorisation.

ECHA's website now provides detailed information on the import and export of certain very hazardous chemicals and pesticides which are subject to the Prior Informed Concern (PIC) Regulation.

A new, state-of-the-art review of test methods and computational approaches has been produced for ECHA by the European Commission's Joint Research Centre (JRC). It promotes the replacement, reduction and refinement of animal experiments in the safety assessment of chemicals.

The first mandate of the Chair of ECHA's Management Board, Nina Cromnier, expired on 30 September and the Deputy Chair, Martin Lynch, retired in July. The Management Board re-elected their Chair and elected a new Deputy Chair in its meeting on 25 September.

The Canadian Government launched its Chemicals Management Plan (CMP) in 2006. It aims to make sure that Canada meets the 2020 sound management of chemicals goal. ECHA Newsletter spoke with Jake Sanderson, Manager of Horizontal Policy and Planning in Environment Canada, to find out how the implementation of the plan is going and what role international collaboration plays in chemicals management.

Nanotechnology offers great opportunities, for example in the environmental and energy sectors as well as in products such as cosmetics and medicine. However, it is essential for nanotechnology applications to be safe while taking advantage of the opportunities that they offer. The regulation of nanotechnologies is therefore necessary to guarantee that human health and the environment are protected.

REACH and CLP requirements are the same for all companies, regardless of their size. But when it comes to implementing the law, what works for large businesses may not be a solution for small and medium sized ones (SMEs). The Belgian Federation for Chemistry and Life Sciences, essenscia, has found a way to make the experience of large companies beneficial and valuable to SMEs.