Helsinki within REACH
Editorial by Annemaria Ojanperä
A Global Reaction to Chemicals
ECHA Corner
Performing CSA and preparation of the CSR are Challenges
Introducing an HRC Service Provider
The Magic of Midsummer and Midnight Sun
Chemistry Quotes
Gateway to the European Chemicals Market
Editorial by Annemaria Ojanperä
The Clock is Ticking
Among other things, this issue of “Helsinki within REACH” gives you a broad coverage of the major events that just took place in Helsinki: The ECHA’s Second Stakeholder’s Day on 27 May, organized back-to-back with the first Helsinki Chemicals Forum on 28-29 May.
Both events attracted a great number of attendees from around the globe. ECHA’s stakeholder event focused on more practical issues and guidance to industry in REACH implementation, whereas the HCF drew attention to the broader topics that the chemical industry is facing these days.
If one should pick one message to be highlighted regarding REACH, it is the urgent call from ECHA: Regarding the SIEF formation, the clock is ticking – if companies wish to achieve the first registration deadline at the end of November 2010, they need get moving now! All SIEFs should be formed and be operational by early autumn this year. ECHA has launched an awareness campaign to this end, and is providing support on its website.
The ECHA’s Stakeholders’ Day was webcasted by HELSINKI REACH CENTRE especially to enable the more distant audiences to follow the event. This was without a doubt a welcome option during these economic times, as many companies have been obliged to cut down on travel. The new technology constantly provides us with new channels of communication. It is fascinating to witness their evolvement – I’m sure in a few years’ time we will have new possibilities in our possession, which none of us can even imagine yet! As exciting – and welcome – as this is, nothing can diminish the importance of face-to-face contact. It was so lovely to see so many familiar faces and make new contacts during these recent events!
This newsletter also provides you with a piece of guidance on the CSA/CSR preparation for registration. More industry-specific guidance is available on the member-only section of our website.
I want to wish you all a wonderful summer from the country of the midnight sun!
A Global Reaction to Chemicals
The first Helsinki Chemicals Forum was held from 28-29 June at the Helsinki Exhibition and Convention Centre. The main topics were Competitiveness & Innovation, Chemical Industry Regulation, Safely & Sustainability and Chemistry & Consumers. Moreover, the meeting highlighted the clear need for more global chemical industry regulation.
The speeches, discussions and panel sessions of Helsinki Chemicals Forum will gradually develop the Helsinki Agenda. The agenda aims to define the full scope of the topical and critical issues related to chemistry and its interest groups identified by the panels and participants of HCF.
Panel discussion themes
The panelists of the Competitiveness and Innovation Session noted that in this challenging economic situation, new innovations by the chemical sector should be based on customer needs. Value chain clusters are needed for effective development work. Long term development is possible only if short term innovation has good financial return. “Companies that use raw materials and energy effectively will survive in long run.” said Mr. Per Sandberg from World Business Council for Sustainable development.
REACH was discussed in the Chemical Industry Regulation Session. “REACH definitely affects global trade policy because the EU is one of the largest importers of chemicals and end products,” said Klaus Berend of the European Commission. Even if similar chemical legislation is not applied on other continents, the market forces will cause countries outside the EU to take REACH requirements into account.
According to different chemical industry stakeholder groups, new instruments are needed for global information transfer. The world’s chemical producers have already established a voluntary (Global Product Stewardship) system for gathering and transmitting the information required by REACH throughout the world. The European Commission has suggested a modular system for international chemicals management to share this extra workload in each country.
Better chemicals: a better world
Mr Alain Perroy, the Director General of Cefic – The European Chemical Industry Council – and the moderator of the Safety and Sustainability panel session, stressed that global commitment by the chemical industry also generates results locally. The chemical industry plays a key role in securing the wellbeing of the population and the environment. One of the key messages to emerge was that sustainability is not a status but a dynamic, continuous process.
The panelists of the Chemistry and Consumers session stressed that it is very difficult for consumers to get a full picture of the chemicals in our everyday products. There are various sources of information out there, but their reliability is difficult to check. The REACH Regulation contributes to product safety by generating a lot of data about chemical substances. Considerable effort must be taken to raise awareness; it is essential that this new information about chemicals and their harmful effects reaches end users. This is already being done through voluntary initiatives, but there is always room for improvement. And this is where the Helsinki Agenda “comes into the picture”.
The entire Helsinki Agenda can be found on the HCF web page www.helsinkicf.eu .
Helsinki Chemicals Forum 2010 will take place from May 20th to 21st 2010. The general theme will be Chemistry & Climate Change.
ECHA Corner
Stakeholders Unite
They came to Helsinki from all parts of the globe - from 33 different countries. On 27 May, 300 of them gathered at the modern and well-equipped Helsinki Fair Centre, and 270 more followed via the webstream provided by HELSINKI REACH CENTRE.
All were participating in the 2nd Stakeholders' Day, a vital, reoccurring event meant to contribute to the development of the constructive relationship, transparency and dialogue between ECHA and its stakeholders. The participants discussed the urgent need for companies to work together and share data in order to prepare joint dossiers for the registration of each chemical substance.
An Excellent Balance of Speakers and Speeches
There were 3 main topics at the conference: the registration process, preparation of registration dossiers, and public consultations. The SIEFs theme ran through all sessions. There were presentations from both ECHA and Stakeholders, and the popular Q&A sessions were longer this time.
"Companies throughout Europe are preparing to register chemicals by the end of November next year and ECHA is doing its best to encourage them to make urgent progress in the Substance Information Exchange Fora, so they don't miss that crucial date." said ECHAs Executive Director, Geert Dancet.
There was a wealth of information given by the experts. Among others, the speeches included such titles as: From Pre-registration to Registration; From Pre-SIEFs to SIEFs; Preparation and Submission of Registration Dossiers and ECHS's First Experiences; Completeness Check, ECHA's Approach; Chemical Safety Assessment and Reporting Tool; Public Consultation, Authorization and Guidance; Participation of Stakeholders in the Consultation Process, Consultations on Guidance Documentation, Seven priorities for Optimizing implementation of REACH etc. However, just as important was the opportunity to speak with the ECHA staff and other stakeholders.
New Info on the Web
In conjunction with the Stakeholders’ Day, two new web sections were launched on the ECHA website, Help and SIEF. The Help section provides easy access to all the technical documents, and Helpdesk support that companies may need when preparing and submitting their dossiers. The SIEF section gives a brief overview of the critical information on SIEFs and how to prepare for registration under REACH.
The Stakeholders’ Day covered a lot of issues and many questions and comments were presented by the participants. Even though many points have now been clarified, there will be many more challenges, problems, queries and uncertainties ahead on the road to the 2010 registration. ECHA will organize the next stakeholder event in late autumn 2009. Certainly there will be a lot of interest in this event, so perhaps you should plan to be in Helsinki, or following it on the Web.
Time to Get Moving
ECHA's recently launched an awareness campaign called, "The Clock is Ticking - Form Your SIEF Now". They intend to raise awareness of the urgency for companies to take action to meet the first substance registration deadline of 30 November 2010.
The campaign was started at the request of industry organizations who realize that some companies are not taking this deadline seriously enough.
According to ECHA's Communication Director, Lindsey Jackson, the campaign has 3 focal points. The first is removing any barriers that are in the way of getting going SIEFs, and for the Lead Registrants to make themselves known to ECHA and take responsibility for the work. "We are getting feedback from various sources of what those barriers are, and we're seeking to provide extra guidance. Or, where there is something we can resolve, we will do our best to find a solution."
Spreading the Word
The second point is to raise awareness of the urgency. "ECHA has found that large-scale producers are taking action in SIEFs because they have the resources to do it. However, smaller companies by contrast are relieved to have completed pre-registration and are taking a breather because they believe there is plenty of time...but they are mistaken." In order to get the urgency message out ECHA hopes to enlist the help of Industry associations, national authorities and the media.
The third point is to offer a sort of VIP service for Lead Registrants. ECHA can't offer that level of service to every company because there are tens of thousands of them and only 250 ECHA staff. "However, after a Lead Registrant is elected by its members, we want to enter into a dialogue with them, offer them a special monthly webinar, talk them through particular issues, answer their questions and, we are looking into the possibility of providing a VIP help desk," Jackson says.
In addition, the campaign will promote examples of the best practices for companies who are well advanced in the registration process. “It is encouraging to see that some companies are doing the right thing. Others can learn about how those companies are doing it and what makes that successful. The aim is to spread good ideas, give concrete examples and let companies learn through shared experiences.”
The campaign banner is available on ECHA's website and is free for all to use.
Difficulties of Dossiers
The pre-registration process was extremely easy, however, registration requires a large dossier which is more difficult to complete correctly. So it's no wonder that many of the submissions to ECHA have been returned.
According to ECHA director Christel Musset, around 50% of the dossiers have been sent back on the first attempt. Reasons for the rejections are: incomplete or missing information, business rules not being followed or a missing or poor justification.
One of the main causes of the submission problems is that the software is new and the companies are not yet used to it. Consequently, there seems to be a learning curve and upon the second submission, most dossiers have been able to make it through. In the near future, ECHA is planning to provide a technical completeness module to help improve the quality of first submissions.
Moreover, ECHA seems to have a positive attitude toward the whole process: "ECHA is also very receptive to feedback. At our end, we hope to make the process easier and clear up any misunderstandings," says Musset.
Performing CSA and preparation of the CSR are Challenges
The preparation of registration dossiers for first group of phase in substances is underway. High tonnage and certain classified hazardous substances must be registered next year and there is not much time for dossier preparation.
Typically a SIEF/lead registrant or consortia has an administrative role and consultants do the practical work. What does the practical (and it’s often quite expensive) work actually mean? What is the Chemical Safety Assessment? How do the consultants know what has to be done?
REACH is based on the principle that industry should manufacture, import or use substances or place them on the market in a way that human health and the environment are not adversely affected. The chemicals safety assessment/report (CSA/CSR) is the instrument to demonstrate this. The main technical and timely challenge is the development of the CSA report in time before the first registration deadlines. For all classified substances, the process will result in the preparation of the famous new instrument: Exposure Scenarios (ES). Given the very limited timeline registering companies have for the first phase, these are indeed challenges. Of course, in addition to these technical and scientific challenges, the companies themselves have other challenges such as achieving trust in working with competitors and getting the SIEF work going.
The preparation of CSA begins by collection all relevant existing information on the substance. The registrant should perform a thorough, reliable and well documented information gathering. Existing relevant data may be taken from scientific literature (handbooks, databanks, publications…) or other industry/sector specific sources. The choice of what is relevant is up to the registrants. In addition to Annex VI-X information requirements, CSA preparation requires detailed information on manufacture, use and exposure within the EU. However, non-EU manufacturers are not obliged to deliver information on the manufacture/processes/use/exposure of a substance outside the EU.
Data gathering and relevance/quality evaluation is followed by assessment and reporting the intrinsic properties of substances. This includes determining the hazard classification as well as the rationale for non classification when this is the case. Derivation of No-Effect-Levels for human health (DNEL) and Predicted No-Effect-Concentrations for environment (PNEC)) is needed for further risk characterization purposes (“No risk” = exposure level is smaller than DNEL (or PNEC)). Assessment properties relate to persistence, bioaccumulation and toxicity (PBT/vPvB). All this may include generation of new information and/or making testing proposals to ECHA.
Modeling is needed in the CSA process for calculating the environmental distribution and fate of substances (e.g. EUSES), and may also be used instead of chemical analysis in assessment of the occupational/consumer exposure (e.g. ECETOC TRA, ConsExpo etc.). Because REACH strives to avoid unnecessary animal testing, the REACH technical guidance documents provide several opportunities to employ alternative methods. Read across, grouping, category approaches and (Q)SARs are methods that can be used effectively by registrants to fill in data gaps when preparjng the CSA and registration dossiers. Finally, the technical registration dossier (electronically) is generated by applying IUCLID 5 software (CSR as a MS-Word doc attachment).
The goal of the CSA assessment is not just to establish whether or not there is a risk, but to identify and describe the conditions under which risks are controlled. Risks are regarded controlled when the exposure levels do not exceed the no effect levels (DNEL or PNEC). For substances where no-effect DNEL/PNEC levels cannot be determined (certain CMRs and PBTs), the risk characterization and management options consist of semi-quantitative or qualitative assessment of the likelihood that adverse effects are avoided. This means, for example, that emissions and exposures are minimized by the implementation of the ES and for physico-chemical hazards, the likelihood and severity of an event occurring due to these properties has to be negligible.
In principle, the REACH risk assessment and CSA process is well instructed. The guidance documents cover detailed guidance for a range of essential REACH processes as well as for specific scientific and/or technical methods that industry needs to employ under REACH. The guidance documents on CSA were drafted and discussed within the REACH Implementation Projects (RIPs) led by the EU Commission. They involved stakeholders from EU Member States, industry and non-governmental organizations. In principle, the guidance should cover all technical aspects of REACH and CSA. This requires far too much. The CSA guidance gives a general framework for CSA preparation, and currently the existing guidance is best suited for mono constituent organic substances.
Therefore, technical and scientific challenges are still met by registrants/consortia/consultants in preparing registration dossiers and CSAs for “non standard” substances such as metals and metal compounds, UVCBs, recovered substances and substances originating from waste materials. In conjunction with ECHA guidance, registrants are advised to consult industry specific guidance, and be prepared to find completely new solutions and answers to questions and issues where existing guidance is not beneficial.
Industry-specific guidance and tools are available in the member-only section of the HRC website.
Introducing an HRC Service Provider: ChemADVISOR
The Right Advice and Information
“One of an Only Representative’s (OR) key challenges is to bring effective support to overseas clients with a wide variety of experience and knowledge of the European chemical marketplace,” says Wolfgang Urhahn, Regulatory Compliance Specialist at ChemADVISOR.
“We recognize that a “one size fits all” approach cannot meet our customer’s needs. As your Only Representative, ChemADVISOR is able to provide customized levels of service to meet your company’s representation, staffing, and technical requirements.”
ChemADVISOR started as a one-woman operation in 1986. It has successfully grown into a global company able to provide a wide range of expertise for players in the chemical industry. However, it has always maintained its reputation for reliability and professionalism.
In 2008, the company began offering REACH products and services. For example, ChemADVISOR can serve as an Only Representative for non-EU entities exporting substances into the EU which qualify for “late pre-registration,” non-EU entities filing an immediate non-phase-in registration and non-EU entities who currently employ another OR and wish to switch to a different services provider. There are three different levels of service available: (1) RoR basic with a minimal level of services to allow REACH registration. (2) RoR Basic SIEF + with technical, regulatory and administrative expertise but allows clients to maintain control of critical decisions. (3) RoR Advanced SIEF + which allows the client to fully rely on ChemADVISOR’s expertise and guidance.
The company offers wide-ranging REACH consulting services, classification & labeling, dossier preparation and submission, as well as third party representative and SIEF representation services. The LOLI Database (List of Lists) contains extensive REACH and REACH-related regulatory data. Furthermore, ChemADVISOR has years of experience in authoring Safety Data Sheets (SDS) in all European languages and in the classification and labeling of substances and preparations.
Other offerings of the company include REACH training such as REACH Essentials, ChemADVISOR’s REACH Practical Implementation Course, IUCLID5 User Training Course, and On-Site REACH Training. Webinars are also available to disseminate the latest expertise and information about the REACH situation. In addition, the company has REACH resources addressing legislation and official guidance, international initiatives, and exposure estimation.
Clients can choose from a variety of valuable consultation, support, training and assistance. They just have to decide what they need, and ChemADVISOR can do the rest. www.chemadvisor.com
The Magic of Midsummer and Midnight Sun
Unlike some of the other Finnish holidays, on Midsummer you don't get the feeling that you "have to" have a good time. There is a much more relaxed atmosphere. It doesn't really matter what you do and where you are, you are just happy to be at the high point of summer, feeling the magic of the white nights.
The traditional Midsummer (Juhannus in Finnish) was celebrated on the 24th of June, but I guess some modern Finns decided the holiday would be more convenient on a Saturday. Hence, it can fall on any date between the 20th and the 26th of June. Midsummer was originally a pagan celebration, but the church has made the holiday more acceptable to the religiously inclined by slipping John the Baptist into the package. And to make patriots happy, it is an official flag day.
In the old days girls used to lean over wells naked in order to see their future groom's reflection. Even if the naked girl didn't see any reflections, she probably ended up with plenty of potential grooms lurking around the well. Another quaint custom was that women would roll around naked in wet grass to cast some kind of romantic spell. Women would also gather seven kinds of flowers or put nine herbs under their pillows believing this to be an aphrodisiac. And what did the men do? What they always do in situations of uncertainty: build something. In this case they put up giant Midsummer poles.
There are many ways for Finns to spend Midsummer. Some like to be out on an island in the middle of the Åland archipelago, or in a western Finnish village listening to tango music, or on a central Finnish lake enjoying a special cruise, or even in the wilds of Lapland. In Helsinki, a traditional fest is held on the island of Seurasaari each year. Here, the Finn and visitor alike will encounter fortune tellers, wood carvers, and performers. The can enjoy freshly-made pancakes, home-made beer and, of course, the vital makkara sausage. Ordinary makkara becomes much more appetizing when well-burnt over an open fire, or at least on Midsummer it does. Then there is the folk music, the folk dancing, the folk games, and folks being very friendly to each other. The finale comes when they light an enormous bonfire, and a newly married couple is rowed around in an old-fashioned boat.
Unquestionably, most Finns want to spend this holiday at a summer cottage. Activities may include sauna, swimming, a bit of touring in a motor boat, singing; and for dinner, grilled meat, smoked fish and new potatoes to be enjoyed while surrounded by verdant forest. And for those energetic enough, old-fashioned dancing until early morning is a must. Admittedly, there is nothing remarkable in this routine, but on Midsummer it all adds up to a wondrous experience. Because there is definitely magic in the air. And if you don’t believe me, come to Finland and find out for yourself.
Chemistry Quotes
To think is to practice brain chemistry. - Deepak Chopra
For me chemistry represented an indefinite cloud of future potentialities which enveloped my life to come in black volutes torn by fiery flashes, like those which had hidden Mount Sinai. Like Moses, from that cloud I expected my law, the principle of order in me, around me, and in the world. I would watch the buds swell in spring, the mica glint in the granite, my own hands, and I would say to myself: I will understand this, too. I will understand everything. - Primo Levi
Better living through chemistry. - Friedrich Nietzsche
Comment by a physical chemist on being shown a successful experiment: "That's all very well in practice, but will it ever work in theory. - G. Hill
Chemistry is all about getting lucky
- Robert Curl
Chemistry is not all soulless activity like it may be presented to portrayed, there is a lot of scope for other things. - Lewis Gilbert
Few scientists acquainted with the chemistry of biological systems at the molecular level can avoid being inspired. - unknown
Chemistry: that most excellent child of intellect and art. - Cyril Norman Hinshelwood
Gateway to the European Chemicals Market
HELSINKI REACH CENTRE (HRC) supports non-EU industry associations and non-EU companies to fulfill REACH requirements by bringing them together with the HRC pool of REACH specialists. Furthermore, HRC aims to enhance creation of REACH services in the Helsinki capital region.
How to become a member? Where can you get further information?
In order to join the HRC network and enjoy the benefits of the membership, you can easily register on-line via our website at
http://www.helsinkireachcentre.eu/.
You may also contact the HRC secretariat directly for any information on our services:
Annemaria Ojanperä
Programme Manager
T +358 9 3193 6541
M +358 400 391 525
annemaria.ojanpera@helsinkireachcentre.eu
Riku Rinta-Jouppi
Legal Advisor
T +358 9 3193 6541
M +358 40 5347 514
riku.rinta-jouppi@helsinkireachcentre.eu
