CIR 2012

The BPD conference was a great success with many controversial issues being raised ranging from mutual recognition harmonisation to dual regulation.  It all got a bit heated at one point with industry raising some tough questions it has to be said! Regulators, ECHA and The European  Commission delivered some fantastic presentations as did industry experts; their contribution was appreciated by all. The fee regulation was addressed and some new important deadlines were bought into the spotlight.

It is clear that this industry is facing a time of change and those that will be most affected are the SMEs….. Will they survive? (Those SMEs who attended are most certainly at an advantage as it seems some SMEs are not even aware of the changes that lie ahead). Soon it will be too late. Preparation needs to start now!

Does the BPR stifle innovation or is it actually going to help organisations in the long run? Is the Biocide Sector following the trend of the Agrochemical Industry?  This is all food for thought… what do you think? Comments are welcome.

CIR 2012 is here! AgChem Forum has kicked off to a great start with interesting discussions and networking. Here are some of our tweets, live from Barcelona:

AgChem Forum 2012 begins with a plenary session discussing how to measure sustainable intensive agriculture #CIR2012

EFSA feedback on the progress in the peer review of active substances #CIR2012

In stream 2 @Syngenta are looking at the experiences of 1107 in human health and the new data requirements #CIR2012

Now discussing dermal absorption from a MS and industry perspective #CIR2012

Soil risk assessment seems to be an area of concern for industry #CIR2012

Exhibition hall is very busy. Over 500 attendees! #CIR2012

If you’re interested in who’s attending CIR 2012, and which companies they’re representing, check out our charts below. If you want to see which companies you could network with in 2013, take a look….

List of attending companies at AgChem Forum 2012:

Twitter – for all the live tweets from CIR 2012 follow us @InformaCIR

Gavin Hall, Head of Licensing Administration, VMD and Chair of the CMDv Legislation Working Group, UK

What’s the biggest challenge in your role currently?

I guess the biggest challenge in my role is similar to that faced by many in the National Competent Authorities of other Member States. The current economic climate means we have to do more with less – in other words we have to work smarter. Running alongside this is the need to devote resources to consider and develop proposals for the new legislation; whilst maintaining business as usual. We now have an opportunity to introduce legislation that would benefit the veterinary sector for the next 10-15 years and we need to make this work.

Can you provide a brief retrospective of 2012 so far – what has been accomplished by your team, which new challenges emerged and what’s brewing for 2013?

I think for me the accomplishment is continuing to undertake business as usual in a changing environment. Over the last six months or so the team has been taking forward e-ways of working, building on the success of e-submissions and scanning of paper based applications. Furthermore, despite the demand on resources, the VMD has continued to deliver against demanding targets and published standards.  The VMD still does not have any application submission slots and we are happy to meet with applicants to discuss potential projects and to provide advice that helps the industry.

Much of what we do has a European dimension and the VMD is committed to playing its full part. I believe CMDv has made, and will continue to make, a difference. The relationships between Member States have been enhanced and changes made to the benefit of both the industry and regulators.

What’s the main objective of your talk at the conference?

To raise awareness of the UK position in relation to some of the proposals put forward for consideration as part of the legislative review.

Which talks are you looking forward to hearing the most and why?

I know many of the speakers and know that their presentations will be interesting and thought provoking. As a regulator though, I would be interested in hearing topics presented by industry – e.g. what are the barriers caused by disharmony and what are the regulatory requirements from the USA and how does this impact on companies who develop products for both the European and American markets.

For more information on the agenda and Gavin’s presentation please download the brochure.

Visit the website for more information.

Name: Dr Bernd Friede
Job Title: Corporate REACH Compliance Manager
Company: Elkem

1. When did you first get involved with REACH?

In 2005

2. Please can you tell me a little bit more about your presentation?

REACH is enforced differently in different member states. The metal industry experienced quite different REACH inspections in France, Norway and Iceland. The presentation should give a better understanding on how inspections work and how to prepare for it.

3. What do you hope that the audience will “take away” from your presentation?

• Know where to find information on FORUM activities
• How to prepare for a REACH inspection

4. Is there any material delegates should refer to before your presentation? Any publications or websites that you can recommend?

Not necessary. For interested delegates that want to be prepared, the websites of Forum including the REACH-en-force 1 and 2 reports, and the REACH information portal for inspectors (RIPE) might be ueful.

http://echa.europa.eu/doc/about/organisation/forum/forum_work_programme_2011-
2013.pdf
http://echa.europa.eu/doc/about/organisation/forum/mcri_minimum_criteria_reach_inspecti
ons_2011.pdf

5. What do you see as some of the major challenges in the REACH field in the future?

• Harmonisation of classification and labelling (especially in the light of contradictory C&L in ECHA’s inventory)
• Whether or not nanomaterials require specific testing
• The role of the customs authorities in REACH enforcement and tracking defrauders

6. To end on a lighter note, please tell us an interesting fact about yourself!

I enjoy salsa dancing, also went travelling

________________________________________________________________________________________

For those attendees who wish to read up and prepare before they attend CIR 2012, please see below for our recommended reading list from Chemical Watch:

http://chemicalwatch.com/11787/substitution-support-database-adds-german-list-of-hazardous-substances

http://chemicalwatch.com/11786/european-commission-publishes-draft-amendment-to-annex-xvii

http://chemicalwatch.com/11789/echa-publishes-new-guide-to-preparing-toxicological-summaries-for-reach

http://chemicalwatch.com/11785/echa-announces-new-harmonised-cl-intention

http://chemicalwatch.com/11653/echa-announces-six-harmonised-cl-intentions

We caught up with some of the speakers from the 2012 European Chemicals Policy- REACH event to find out what they see as the major challenges in the REACH field in the future.

Steven Signs, Director, Toxicology and Product Risk Assessment, The Lubrizol Corporation, France

“Needless to say, identifying and communicating conditions of safe use for mixtures will be a major challenge. For many companies, especially small and medium sized enterprises, fulfilling registration and chemical safety report preparation obligations will also be challenging for the 2013 and 2018 deadlines in large part due to the greater number of substances to address, most of which are data poor. Integrating REACH compliance responsibilities into business practices (for example, substance volume monitoring, raw material equivalency, importation tracking) will be a challenge. In addition, compliance with operational conditions and risk management measures defined by the supplier Exposure Scenario may pose a challenge, not to mention the impact of complying with strictly controlled conditions for transported isolated intermediates.”

Bernd Friede, Corporate REACH Compliance Manager, Elkem, Norway

Harmonisation of classification and labelling (especially in the light of contradictory C&L in ECHA’s inventory)

Whether or not nanomaterial’s require specific testing

The role of the customs authorities in REACH enforcement and tracking defrauders

While Roger Van der Linden, Group Manager Product Stewardship and REACH, Borealis, Belgium expressed how a

“fair and professional enforcement is the key to a sustainable REACH.”

Steven will be talking about the preparation of extended safety data sheets and exposure scenarios for mixtures, addressing the process for safety assessment of mixtures containing multiple hazardous substances at European Chemicals Policy at 10.00 am on Thursday 6 September 2012 at the Hotel Fira Palace in Barcelona.

Bernd will be sharing lessons learnt from REACH enforcement inspections in 3 different member states at 16:00pm on Wednesday 5 September 2012. While Roger will provide a status report and practical advice for the preparation for the 2013 deadline at 14:30pm on Thursday 6 September 2012.

For more information on this event, or to book today please visit the website.

The Scientific Opinion on Evaluation of the Toxicological Relevance of Pesticide Metabolites for Dietary Risk Assessment was published on 26 July 2012.

Please click here to download our recommend reading  list, for this and many other articles. Read up on hot topics ahead of this year’s AgChem Forum, taking place on 5 – 6 September 2012, Hotel Fira Palace, Barcelona

Stream 2 Human Safety: Toxicology and Exposure dedicates a whole session to dietary exposure assessment.  Hear feedback directly from EFSA during the morning of Day 2:

EFSA: Pesticide residue monitoring in Europe

• Monitoring programmes in the EU

• EFSA data collection system

• Results of the monitoring activities

• Use of the monitoring data in the consumer exposure assessment

Daniela Brocca, Scientific Officer, European Food Safety Authority (EFSA), Italy

Other conference highlights from this stream include:

Dermal absorption of pesticides -How many studies should be done? How should these be conducted? Find out with presentations from MS and industry and have all your questions answered during our interactive panel discussion

Impact of 1107 and the new data requirements in human health -Syngenta assess the challenge of generating globally complainant data packages

AgChem Forum is composed of 3 conference streams and we offer you over 50 presentations to choose from including vital feedback from EFSA on the following topics:

• EFSA: Progress in the EU peer review of active substances
• EFSA: Scientific opinion on clustering and ranking of emissions of plant protection products from protected crops to air, groundwater and surface water
• EFSA: Scientific opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of PPPs in soil
• EFSA: Scientific opinion on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera and Bombus sp.)

3 Conference Streams • 58+ Speakers • 11+ Hours of Networking Time • 6 Interactive Panel Discussions

Please visit www.informa-ls.com/agchemforum for further event details

Joan Harrigan Farrelly, Director of the Antimicrobials Division at the EPA, will be presenting at Informa’s Biocidal Products Directive conference, part of CIR 2012. For more information on this event please visit the website, or download the event brochure.

This event offers an exclusive opportunity to explore the most recent changes and current advancements that relate directly to the Biocidal Products Directive and the New Regulation. Below is the abstract of Joan’s presentation, to hear her talk in full, why not book onto this event today?

Title: Harmonizing the Regulation of Antimicrobial Pesticides

Abstract: The U.S. EPA is responsible for regulating over 4,700 antimicrobial pesticides. This presentation will address ground-breaking decisions that the Agency is making on new types of products (e.g., nanomaterials, treated articles, etc.), how it is developing and implementing new efficacy test methods (e.g., UDM, OECD methods, etc.), and what alternatives to animal testing are being considered. In addition, the EPA would like to explore new concepts such as Disinfection Hierarchy, Global Joint Reviews and post-registration efficacy testing that could help conserve limited resources while still assuring protection of human health and the environment.

Visit the website today for the latest event info, online booking and the event brochure.

We asked Gavin Hall - Head of Licensing Administration at the Veterinary Medicines Directorate UK and Chair of the CMDv Legislation Working Group – to provide us with a brief retrospective of  what has been accomplished by his team so far in 2012, which new challenges have emerged and what’s brewing for 2013…

“I think for me the accomplishment is continuing to undertake business as usual in a changing environment. Over the last six months or so the team has been taking forward e-ways of working, building on the success of e-submissions and scanning of paper based applications. Furthermore, despite the demand on resources, the VMD has continued to deliver against demanding targets and published standards. The VMD still does not have any application submission slots and we are happy to meet with applicants to discuss potential projects and to provide advice that helps the industry”

“Much of what we do has a European dimension and the VMD is committed to playing its full part. I believe CMDv has made, and will continue to make a difference. The relationships between Member States have been enhanced and changes made to the benefit of both the industry and regulators”

Gavin will be talking about the simplification of the authorisations landscape in Europe, addressing findings of the consultant’s report leading up to the revision of the Directive at Regulation of Veterinary Medicines at 9.10 am on Wednesday 5 September 2012 at the Hotel Fira Palace in Barcelona.

For more information on this event, or to book today please visit the website.

Don’t miss vital feedback from EFSA on the following topics at this year’s AgChem Forum event:

• Progress in the EU peer review of active substances
• Pesticide residue monitoring in Europe
• Scientific opinion on clustering and ranking of emissions of plant protection products from protected crops to air, groundwater and surface water
• Scientific opinion on the science behind the guidance for scenario selection and scenario parameterisation for predicting environmental concentrations of PPPs in soil
• Scientific opinion on the science behind the development of a risk assessment of plant protection products on bees (Apis mellifera and Bombus sp.)

Stream 1: Regulatory Frameworks
Hear first experiences and interpretations of 1107/2009 including the zonal procedure, AIR 3, comparative assessment and the registration of co-formulants

Stream 2: Human Safety
Examine cumulative and aggregate risk assessment methods and ensure best practice for exposure assessment and toxicology testing

Stream 3: Environmental Safety
Assess the new data requirements under 1107/2009 for ecotox and fate and gain feedback on EFSA’s scientific opinions on soil risk assessment, bees and protected crops

For all conference info, speaker updates, sponsors and exhibitors, please visit the website or download the brochure.

Joan Harrigan-Farrelly from the EPA has joined our Biocides conference speaker panel. If you have any questions for Joan and the EPA then please post them here or tweet us @InformaCIR. What would you like them to discuss? Which topics are you interested in hearing from the EPA at the event?