ECHA

This summer at ECHA has been filled with preparations for the new Biocidal Products Regulation which will apply from 1 September 2013. We have been working with this date in mind since the regulation entered into force on 17 July 2012, but the pace has intensified during the last couple of months.

Safer biocidal products, less animal testing and equal treatment of the active substance suppliers are some of the changes that the new Biocidal Products Regulation introduces. The application date, 1 September 2013, is the first of many important milestones of the regulation.

What is the role of the European Commission under the new Biocidal Products Regulation? ECHA Newsletter spoke with Mr Pierre Choraine, the Biocides Team Leader in the Commission, to find out more about the upcoming changes, improvements and challenges brought by the regulation.

Katariina Sairinen, Regulatory Affairs Specialist at the Finnish healthcare company Algol Pharma, has been closely following the regulatory developments on biocides during the past years. "As the legislation changes, everyone has to learn - both authorities and companies. The challenge for SMEs is, of course, the question of resources," she says.

The new Biocidal Products Regulation requires that the Member State competent authorities provide advice to all interested parties about their responsibilities and obligations under the regulation. To this end, many competent authorities are establishing a national helpdesk, which ECHA will support. ECHA Newsletter interviewed helpdesk representatives from Finland, the Netherlands and Slovenia to learn how these countries are building up their service to the biocides industry.

Companies will be using three IT-tools to prepare and submit their biocides applications once the Biocidal Products Regulation enters into operation.

ECHA's first Biocides Stakeholders' Day, held on 25 June, aimed to ensure that companies are aware of their roles under the Biocidal Products Regulation (BPR), the available tools and assistance provided to help them meet their obligations.

ECHA and its stakeholders have signed up to improving chemical safety reports and extended safety data sheets. More stakeholder organisations are invited to join in this long term collaborative effort.

Handling extended safety data sheets (eSDS) as a downstream user is challenging. In addition to the existing obligation to follow the supplier's advice in the main body of the safety data sheet, the downstream users now have to carefully check if their own uses are covered in the exposure scenarios received, and whether their conditions of use are equivalent to those specified in the exposure scenarios.

ECHA is combining a targeted, concern based approach with full compliance checks to improve the quality of information and ultimately the safety of chemicals.

ECHA received its first application to use a substance on the REACH Authorisation List in May. The application has been submitted for the use of DEHP in the manufacture of aircraft engines. The eightweek public consultation to find safer alternatives was launched on 14 August. This last process of REACH – application for authorisation – has now officially started.

ECHA's Management Board has prolonged the term of office of ECHA's Board of Appeal chair Ms Mercedes Ortuño and four alternate members for five more years.

Five years ago, Eurometaux and its members embraced the principles of the REACH legislation, committing to provide the required efforts to make it a transparent and efficient chemicals management tool. While inorganics account for less than 10 % of the number of substances on the EU market, their volumes and daily use by society is much larger, accounting for more than 50 %. These aspects, as well as the hazard profiles of a number of metals, justify why the sector tries to appropriately address both the generic requirements and the specificities of inorganics.

The German Institute of Occupational Safety and Health of the German Social Accident Insurance (IFA) has published an online database of derived no-effect levels (DNELs) based on information retrieved from ECHA's website. This database provides easy access to a collection of DNELs relevant to workplaces for people involved in occupational safety and health within companies, research institutions and authorities.

"Only by listening to the opinions of our stakeholders are we able to understand better and only by understanding, will we be able to regulate better," said Antonio Tajani, the Vice President of the European Commission in his opening at the Technical Workshop on the Review of REACH held in Brussels on 27 June. The aim was to listen to the views of SMEs, which deal with the challenges of the regulation every day, and find practical solutions. ECHA Newsletter reports back on some of the views presented at the workshop.

Croatia joined the European Union on 1 July 2013, taking the total number of EU Member States to 28. The REACH, CLP and biocides regulations now apply to companies established in Croatia.

The 2020 goals and the sound international management of chemicals, chemicals in products, regulation of nanomaterials, listing of chemicals of concern, and combination effects were the topics discussed at the global Helsinki Chemicals Forum from 18 to 19 June 2013.