- ECHA takes on new tasks
- ECHA's second lead registrant workshop prepares industry for the 2013 registration deadline
- ECHA Guidance - Why? Who? How?
- ECHA reaches out to SMEs
- ECHA joins forces with European trade unions to promote employers' obligations under REACH
- The new biocides regulation offers new opportunities for business and industry
- PIC Regulation enters into force
- ENES discusses good practice in deriving and communicating exposure scenarios
- ECHA five years: From a start-up to a well-established authority
- More information on chemical substances to be published on ECHA's website
- Registrants play a role in the substance evaluation process
- ECHA's Management Board adopts the multi-annual work programme 2013-2015
- ECHA prepares Balkan region for EU accession
- New appointments
- ECHA welcomes Croatia
- Bjorn Hansen: "ECHA is centrally important for the EU"
- A Member State perspective: Activities for SMEs in France
- Simplifying Art. 33 (2) requests for consumers - New web tool launched in Germany
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Article related to: Biocides
The new biocides regulation offers new opportunities for business and industry
The Biocidal Products Regulation recently entered into force and the new requirements will apply from September 2013. With just over a year to go, business and industry should already be considering how the changes will affect them.
ECHA established a new unit for biocides at the beginning of this year, which has become fully operational on the entry into force of the new regulation on 17 July 2012. Selections and recruitment are ongoing as the unit will expand next year to prepare ECHA for its upcoming tasks. Chair of the Agency's new Biocidal Products Committee Erik van de Plassche and the Committee Secretary Steve Hollins talk to ECHA Newsletter about how the new rules for placing biocidal products on the market will work.
Biocidal products, including disinfectants, insect repellents and many other products, have been subject to EU law under the Biocidal Products Directive since 1998.
The new regulation, which ECHA has been tasked to play a central role, aims to streamline and simplify the old directive and in doing so deliver an estimated €2.7 billion in savings to industry over ten years. Under the two step approach, companies will still need to gain approval for active biocidal substances and authorisation for biocidal products to sell their products on the market.
But unlike the old system where applications for authorisation of biocidal products had to be made to individual Member States, companies will for the first time be able to seek Union-wide market authorisation.
Committee Chair Erik van de Plassche
Committee Chair Mr van de Plassche says improving free movement across the market is likely to be of economic benefit to many European companies. "This opens the possibility for companies to place their products directly on the entire EU market", he says. Companies can still opt to submit applications at an individual Member State level, which may be of benefit to small and medium-sized companies operating in a smaller market.
There will be a fee to submit authorisation applications to ECHA, which is still to be determined by the European Commission but Mr van de Plassche says companies that opt for Union-wide authorisation will not have the burden of separate application fees and procedures to each individual Member State where they want to do business.
European-wide authorisation will be possible for most biocide product types but excluding a limited number of biocides, for example antifouling products used on ship hulls that will still require applications to be made only at an individual Member State level. Mr van de Plassche says it will be helpful if companies can contact ECHA to inform the Agency if they will seek Union-wide authorisation ahead of the September 2013 deadline. This functionality will be incorporated in the dedicated IT platform, the Register for Biocidal Products, which will be used to submit applications.
BINDING DEADLINES AND ANIMAL WELFARE
Another positive change that the new regulation delivers to industry are the fixed timelines, Committee Secretary Steve Hollins points out.
For example, the new Biocidal Products Committee will have to consider new active substance approvals within nine months and new biocidal product applications for Union authorisation within six months, in contrast to the open-ended timeframe under the old system. This means that "industry will now have predictable timelines in which to get their products onto the market", Mr Hollins says. "But meeting these strict deadlines is going to require a considerable cultural change for everybody involved", he says.
Another important change business needs to be mindful of is the compulsory sharing of data to reduce animal testing. Similar requirements are already in place under the REACH Regulation.
NEW RULES FOR TREATED ARTICLES AND ALTERNATIVE SUPPLIERS
Articles treated with biocidal products, such as furniture treated with wood preservatives, will now be covered by the regulation. Mr van de Plassche says this will also impact companies based outside of Europe and wanting to operate in the EU market. In order to be able to place treated articles on the European market, companies will have to use biocides that have already been approved within EU.
Another key feature of the new regulation is aimed at alternative suppliers: persons placing biocidal products on the EU market will have to hold the data on active substance, either by submitting their own data or via a letter of access. ECHA will compile a full list of companies that have followed the requirements and from September 2015 onwards those that have failed to comply will be forced to take their products off the European market within a year.
ECHA is working on a new IT tool (Registry for Biocidal Products) to submit dossiers, which is scheduled to be operational by September 2013. The whole application process will be online and ECHA will provide training and information sessions ahead of the IT tool's launch. In addition, ECHA is preparing together with the Commission the necessary guidance. "We are preparing guidance for new elements in the regulation but also considering to restructure the guidance already available under the old system to make it more user friendly", Mr van de Plassche says.
|Steve Hollins highlights that to efficiently implement the new regulation ECHA, the Member States, industry and other stakeholders will have to work together.|
A separate section of the ECHA website containing basic information on the new regulation and processes is already up and running. ECHA will also in 2013 deliver a focused Helpdesk and email address for business with questions and queries about the new regulation.
In summing up, Mr Hollins says successfully implementing the regulation will be a real team effort between ECHA, the Member States, industry and other stakeholders. "ECHA will be sitting in the centre of this, coordinating and facilitating, but we would like to construct a strong partnership with the Member States and the applicants to be sure we can all deliver what the new legislation intends."
Interview by Susanna Dunkerley
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Committee for Risk Assessment:
Committee for Socio-Economic
Biocidal Products Committee:
Member State Committee:
4-8 February (tentative)
Management Board meeting: