Helsinki within REACH
Editorial by Annemaria Ojanperä
HCF 2010: Calling for Regulatory Convergence
ECHA Corner
CSA- Exposure Scenario building – Modeling and Measurements
Introducing an HRC Service Provider
Gambling Without Guilt
Business Advice
Gateway to the European Chemicals Market
Editorial by Annemaria Ojanperä
HRC Expands – Welcomes EU-associations
So far HRC has focused on helping the non-EU associations, who have the most difficulties in complying with REACH, and lack an overall umbrella organization to look after their interests. Due to public demand, HRC is now reaching out for EU-based associations as well.
The EU’s national chemical industry associations have Cefic, the European Chemical Industry Council as their umbrella organization which gives them information and advice to be passed on to their member companies. However, according to the messages and inquiries we receive from within the EU, there is still a need for more knowledge and practical guidance on REACH and CLP at the grass-root level in different EU member states.
This is where HRC steps in. What we offer is an outstanding opportunity for complementary assistance to the EU’s industry associations and their member companies. More information of the benefits of our membership can be found on the HRC website, and by contacting HRC staff directly.
I want to wish you all a warm and sunny summer!
HCF 2010: Calling for Regulatory Convergence
“Regulation of chemical substances and controlling risks are in everybody’s interests,” said Hannu Vornamo, Secretary General of Helsinki Chemicals Forum (HCF). “New chemicals regulation is emerging around the world – the potential threats in this process are a distortion of competition and protectionism. Support for global harmonization is increasing….”
The second global Helsinki Chemicals Forum was held on 20-21 May 20-21 at the Helsinki Exhibition and Convention Centre. The event turned out to be a great success with 230 key stakeholders from 50 countries attending. During the two days of the conference, a myriad of facts, figures and pertinent information was presented. Discussions and debates, by high-level experts in all areas of the chemicals field, took place formally in panels and informally during breaks. At lunch and at dinner, participants made important contacts, exchanged ideas and traded business cards. In conclusion everybody learned, contributed and took something home.
Thursday: Regulations and Policies
Chemicals Regulation – Global Challenges was chaired by Mr. Charles Auer who has had a 32-year career with the EPA, and was formerly Director of Pollution and Toxics. The group predicted that a global view would influence national legislation, and they discussed the possibility of REACH becoming a globally accepted model. It was noted that many countries outside the EU have shown interest in REACH type legislation including Canada and the US. However, the panelists concluded that REACH may not be the ready-made global solution because it would be too complex, too demanding and too costly for many developing countries.
The panelists saw the Sustainable Development and the 2020 Strategic Approach to International Chemicals Management (SAICM) as a significant target. At the same time they brought up the importance of green chemistry. Emerging scientific technologies such as nanotechnology could be opportunities to solve problems, but they must be studied further to make sure they can be used safely.
Chemical Policies – Emerging Economies was chaired by Khalida Bouzar, Deputy Director of UNEP. Bouzar stressed that UNEP conventions, and recommendations such as the UNs Globally Harmonized System (GHS) provide good examples for emerging economies to implement modern chemical legislation. Moreover, the REACH regulation has been a model some developing countries for establishing their legislative framework. REACH has a positive impact on the emerging economies by allowing access to public information of chemical substances. Furthermore, the recommendation of the Mutual Acceptance of Data by the OECD provides a good platform for exchanging information globally.
According to Dan Steinbock, from the India, China, and America Institute, the chemical industry in developing countries such as Brazil, India and China is growing rapidly. This decade they will surpass the volume of traditional chemicals producers such as the USA and Europe. Therefore, these countries will need modern chemical policies to protect health of the population and protect the environment.
It was noted that global chemical companies bring their own safely and product standards when establishing production in developing countries. Global Product Strategy (GPD) developed by the International Confederation of Chemical Association (ICCA) is a good example of this.
Friday: Being Competitive and Green
Competitiveness – Financial Constraints was chaired by Harri Kerminen, CEO of Kemira Oy. According to Hurbert Mandery, Director General of Cefic, Europe is still a successful global player in the chemicals industry. Europe covers 29% of world chemical sales, and has 29,000 chemical companies of which 96% are SMEs. The European chemicals industry employs 1.2 million people, has revenues of €456 billion and has a trade surplus of 42% However, China is the clear winner in market share, and Europe has lost more than 30,000 jobs in the last recession.
Anthony Owens, Managing Director of Arran Chemicals, believes that there is too much bureaucracy associated with chemical regulations, which makes Europe a sort of “prison”. He believes politicians should have a longer term view in their planning.
Marin Evans of J.P. Morgan thinks that investors are not interested in what kind of regulations prevails, as long as it works and provides a stable business environment. The panelists also agreed that keeping a positive mindset toward innovation in society was important. R & D expenditure is the key factor for future success and should not be reduced.
Green Chemistry – Solution Provider was chaired by Klaus Berend, Head of the Chemicals Unit of the European Commission who discussed the 12 principles of green chemistry. Jerker Lightart, Project Coordinator for the International Chemical Secretariat, added that using these principle make perfect business sense.
Peggy Harris from California Department of Toxic Substances talked about her state’s quest to rethink and redesign consumer products containing chemicals of concert. A practical example of this was presented by Rick Hammers from Columbia Forest Products who told why and how his company made the change to green production. After some initial challenges, their product is now made with 100% green alternative glue.
Lars Gädda, Research Director for the Forest Cluster Ltd, talked about biorefining and its future. He pointed out that there are three prerequisites for innovation: a market must exist, the technology must be in place, and the concept must gain social acceptance.
Onto the Next Forum
Like in all good meetings, many questions were answered and problems solved. However, many new ones arose. Fortunately, the third global Helsinki Chemicals Forum is already being prepared for the 19-20th of May 2011 – and getting ready for the next round of chemicals issues where new questions and problems can and will be addressed. Don’t miss it.
ECHA Corner
ECHA's Man of Science
Derek Knight, who hails from England, is Senior Scientific Adviser at ECHA. He reports to the Executive Director and provides whatever advice is needed on scientific and technical issues.
HRC: How would you describe your work?
DK: Well, I’m sort of a jack of all trades, really. I try to be aware of everything that’s going on at a higher level in science and technical aspects that could impact upon the work of the agency. Moreover, I am on the lookout for issues I should alert the Executive Director on that might affect the running, well-being and reputation of ECHA. This requires working closely with colleagues in the Scientific and Technical Units and Directorates without duplicating what they are doing. It’s rather a second opinion approach.
HRC: Could you give some examples of your duties?
DK: For example, ECHA issues technical guidance on how to do registration dossiers, or conduct a risk assessment for a Chemical Safety Report. Producing this guidance is a complex process developed with input by the public and other interested parties. Sometimes there are issues that need resolving quickly, for instance, industry representatives may have a problem or concern with a particular area of guidance, and will either come to visit ECHA for a meeting or have a phone conference. I’ll sit in on the meetings as a sort of neutral bystander seeing both sides of the argument or scientific discussion. Then I try to facilitate getting a conclusion or compromise. I am like a bridge between industry and the regulators, and also a bridge between scientists and lawyers.
HRC: What are the challenges of your job?
DK: I think the most difficult and challenging part is getting across clear and simple messages to the target audience. Because, universally, industry, NGOs, stakeholders, ECHA, member states, and the EU commission all want REACH to work. And if there are areas where it’s not working, it’s all down to lack of communication and understanding. Messages must be put across so registrants can understand them. We are building on what’s gone on before under the old registration system and the old classification and labeling scheme. To move on, there has to be a change of mindset by industry, because now the burden has been shifted from the regulators to the shoulders of industry. We have to get people in industry to think in a different way.
HRC: What is your science background?
DK: I did my doctorate at the University of Oxford in organosulphur chemistry. Subsequently, for almost 20 years I ran the registration department at a major UK testing laboratory. I was involved with worldwide notification of new substances and biocide registration. This gave me a lot of experience in regulatory science in such areas as chemicals, biocides, plant protection products and medicines as well as working with regulatory authorities and industry. Then I noticed this job at ECHA, and started working in Helsinki in September 2008. I wanted to be at the center of regulatory activity, and this opportunity was too good to miss. So here I am. It has been interesting moving from industry - in a consultancy firm - to a regulation agency. Sort of like a “poacher turned gamekeeper”.
HRC: How do you like living in Helsinki?
DK: I was very pleasantly surprised by Helsinki. I like my Finnish colleagues, the city is safe, and it’s an orderly society which suits my nature and temperament. The summers are gorgeous, and the spring and autumn are very similar to what I’m used to in the UK. However, I’m not very keen on winters - maybe it will grow on me. I find the Finnish language impossible to learn, but fortunately, a lot of people here speak excellent English. So there is no problem with communication.
CSA- Exposure Scenario building – Modeling and Measurements
A Chemical Safety Assessment is required for all registered substances exceeding a 10 t volume. Practically taken all phase in substance registered in 2010 need a CSA/CSR. If the registered substance will be classified according to GHS system (called CLP in EU Europe), registrants need to prepare Exposure Scenarios for the identified uses of the substance.
Exposure Scenario building is actually a risk assessment process. The use of the substance is regarded safe if the exposure level is low enough and remain below the highest derived/predicted no effect level/concentration (DNEL/PNEC). The assessment needs to cover the manufacturing and all identified uses of the substance and the life cycle stages resulting from these identified uses. This will include the waste stage as well (even if waste materials as such are exempted from REACH registrations).
For certain classes of chemicals no safe threshold limits can be given and safe use must be determined by minimizing exposure (e.g. certain CMRs and PBT/vPvB substances).
In all of these cases in preparation of Exposure Scenario information is needed on human and/or environmental exposure. How to get that exposure information? Often the most simple way is to use modeling and existing default emission factors. Normally the models recommended by CSA guidance (ECETOC TRA, EUSES) give relatively conservative (= high) exposure level estimates. These precautious estimates may lead to exposure exceeding clearly the safe levels. If the safe levels (DNELs and PNECs) are already on a realistic level, you may need to improve the exposure estimation and make it realistic to reflect the true conditions and ways of use of the substance.
High quality, measured reliable analysis results and monitored exposure data is very valuable information in this higher tier stage of assessment. No matter, whether the data comes from EU countries or non-EU countries, since a case by case assessment shows if the data can be used to refine and finalize the Exposure Scenario.
In distributing measured data, it is important to attach sufficient and detailed enough background information on purposes of the studies, site information of the applied risk management measures and technics, methods of sampling, analyzing etc. All pieces of additional information can normally be utilized by way or other in building sufficient picture of exposure and the conditions and way the substance is used.
High quality measured values are normally always a better indication of true emissions and exposure over the modeled results. Measured values are the basis for developing new models and improving the old ones.
Arto Kultamaa, Chemest Oy Ltd
Introducing an HRC Service Provider
REACH is EcoMundo's Core Business
“We provide services for the protection of human health and the environment” says Pierre Garçon president and co-founder of EcoMundo. “Our mission is governed by the framework of the REACH regulation. EcoMundo’s solutions include full assistance, dedicated IT tools and expertise embedded within companies.”
EcoMundo is a pioneer in dealing with the complex REACH regulation. During the long and detailed negotiations between the European authorities, industry and other stakeholders, EcoMundo’s founders and current managers had the privilege of taking part in the discussions. Therefore, the company is at the forefront when it comes to know-how in this field.
EcoMundo provides the following REACH-related services:
Registration – Commitment to manage a SIEF-group aiming at submitting the registration dossier to ECHA within an agreed timeline and budget. This includes the formation of the SIEF and the drafting of a working rules agreement, a registration strategy with data gap analysis, the data collection, the generation of required tests, the drafting of Chemical Safety Reports, and the submission of the IUCLID 5.2 dossier.
Classification & Labelling Management – Bringing together pre-registrants in the SIEF for the 2013 and 2018 deadlines while aiming for an agreement on substance classification and labelling. Making sure data on C&L is submitted before the January 2011 deadline thanks to an expert IT tool allowing the classification of your substances and mixtures.
Representative – Representing companies in the SIEF or consortium, monitoring and reporting progress of substance registrations. Taking care of the company’s letter of access acquisition as well as data exchanges with the Lead Registrant and handling the constitution of their individual dossier.
Setting up the Lead Across Platform – After having identified a number of “orphan” substances, EcoMundo took the initiative of setting up the Lead Across Platform. The platform helps industry to register lead compounds which were not already covered by a consortium. EcoMundo is extending this approach to other families of substances such as nickel, manganese, molybdenum, and antimony.
The Holistic Approach
Reach-Factory is a family of IT tools designed by EcoMundo to respond to each and every need generated by the new REACH environment. SVHC-Factory ensures hazardous substance detection in materials within the entire supply chain. Use-Case Factory enables the creation and communication of a substance’s use in the supply chain which in turn allows the creation of all relevant exposure scenarios. SDS-Factory enables the creation and dissemination of REACH-compliant Safety Data Sheets and Worker’s Exposure Sheets. Zen-Reach delivers a full diagnosis of the company’s obligations under REACH, including advice on how to fulfill them.
“Reach-Factory is a solution that any company can afford. It is both flexible and adjustable to the client’s needs and its implementation can be made in stages. The solution is always based on the expertise of the EcoMundo team who constantly follows any changes brought to the REACH environment.”
According to Pierre Garçon, 2010 will see EcoMundo grow rapidly. Considering the massive increase in demand for REACH-related services which is expected, and the ability of the company to respond with innovative solutions, the president’s prediction seems to be sound.
Gambling Without Guilt
When you are gambling at the Helsinki Grand Casino, you are contributing to a good cause. The casino is owned by RAY (Finland’s Slot Machine Association) which controls all gambling machines and tables in Finland, and donates 100% of all profits to charity.
The first slot machines appeared in Finland in the 1920s. In 1937 RAY was established by eight charities together with representatives of the state. The association started its operations a year later, and since them it has been supporting the work of health and welfare organizations with profits from its gaming operations. Besides the casino, RAY operates in restaurants, clubs, arcades and even supermarkets all over the country.
The Helsinki Grand Casino is situated in the tradition-rich Fennia block in the city center. There are 30 gaming tables including American Roulette, Black Jack, Red Dog, Oasis, Punto Banco, and 5 different pokers games. The casino’s 300 slot machines comprise a variety of interesting themes, attractive colors and intriguing sounds. Some of the more popular machines are Derby Horse Racing, Touch Bet Roulette and brand new Sex and the City machines.
The casino was designed by Las Vegas architect Paul Steelman, and is said to be one of the most modern in Europe. He has done a fine job of combining an ultra high tech casino with a beautifully renovated 1920s style area. The pride of the establishment is the show restaurant, Fennia Salonki. The restaurant serves delicious cuisine and has a fine selection of wines. During most evenings a dinner show is available which in the recent past has presented performances with names such as “Tribute to Elvis,” “Sinatra at the Casino” or the “Motown Show.” This entertainment comes with a 4-course themed menu. Moreover, there are several other restaurants, bars and cafés that allow the customers a refreshing break from gaming.
When compared with the great gambling palaces of Las Vegas, or the distinguished casinos of Central Europe, the Grand Casino can neither compare in size nor in intensity. However, it certainly fits right in with the Helsinki nightlife and suites the Finnish character perfectly. So, when you are on your next visit to Helsinki, you may want to drop by…and remember, it’s all for charity.
Business Advice
As in other industries, the chemicals trade is based on sound business practices. A competent manager must listen to lots of business advice and then decide which path to follow. Here is advice given by some of the great minds of the past.
A man is to go about his business as if he had not a friend in the world to help him in it. - Lord Halifax
There’s one sure way to make a businessman worry. Tell him not to. - Leopold Fechtner
Everything which is properly business we must keep carefully separate from life. Business requires earnestness and method; life must have a freer handling. – Goethe
If you destroy a free market you create a black market. If you have ten thousand regulations you destroy all respect for the law. – Sir Winston Churchill
Business, you know, may bring money, but friendship hardly ever does. – Jane Austen
Businessmen are notable for a peculiarly stalwart character which enables them to enjoy without loss of self-reliance, the benefits of tariffs, franchises and even outright Government subsidies. – Hebert J Muller
Few people do business well who do nothing else. – Lord Chesterfield
Try and find something that works and stay with it. – Robb Sagendorph
Those who invented the law of supply and demand have no right to complain when the law works against their interest. – Anwar Sadat
People who knock their employer are under-estimating his value to them.
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
