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by Helen Gillespie, Editor, LIMS/Letter
Most people never forget their very first car. I’ve never forgotten the sports car I learned to use a stick shift in. Nor have I forgotten using the choke to get it to start. Nor have I forgotten bending over the engine or sliding under the car to make quick fixes on the side of the road to get it going again. Nor have I forgotten times when the floor mat got stuck under the accelerator; using my heel to quickly pull the floor mat back was just par for the course. Driving used to be much more of an adventure than it is now and safety wasn’t an expectation.
Times have changed. Safety is now expected, not just in the cars we drive but in the food we eat, the toys we buy, and the products we purchase—from non-toxic paint to flammable-resistant curtain fabric. Hence regulatory oversight has become more complicated, and in many cases contradictory, as safety issues are identified and safety expectations continue to rise.
This is the first of a two-part article that explores the REACH chemical safety regulation that was recently highlighted at the HCF 2010 conference.
ECHA Zeros in on Chemical Safety
The European Chemicals Agency (ECHA) was established to manage implementation of the European Commission’s (EC) chemical safety regulation known as Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) to ensure consistency across the European Union (EU). ECHA is also responsible for the European regulation on Classification, Labeling and Packaging (CLP) of chemical substances and mixtures that amends and repeals the Directive 67/548/EEC (Dangerous Substances Directive) and the 1999/45/EC (Dangerous Preparations Directive). Based on the United Nations’ Globally Harmonized System (UN GHS), CLP introduces throughout the EU a new system for classifying and labeling chemicals.
As part of their charter, ECHA recently hosted the second Helsinki Chemicals Forum (HCF) from May 19-21, 2010 at the Helsinki Exhibition & Convention Centre
in Helsinki, Finland. HCF is composed of two parts, the first of
which is a Stakeholder’s Day where the ECHA teams provides tips for REACH
and CLP registration, introduces new tools, and answers stakeholder questions.
The second part is a two-day forum that delves into key areas affected
by the regulation: global challenges, chemical policies, competitiveness,
and green chemistry. Unlike last year, HCF 2010 started on a much different note. Rather than just listening to stakeholder complaints as occurred at HCF 2009, ECHA has spent the past year proactively developing a range of tools to ease and streamline compliance. In addition, while REACH is still estimated to affect some 50,000 substances, ECHA is now putting the most intense focus on toxic and hazardous chemicals—specifically a short list of some 30 substances that are or shortly will be banned in the EU and thus their presence in any mixture or product must be identified.
Agency Acts Proactively
It is refreshing when an agency listens to criticism and acts upon it. This year, there was greater understanding of the challenges that chemical manufacturers and shippers face and greater support for their efforts to meet the REACH deadlines.
ECHA’s president Geert Dancet presented basic information that most US companies
would have already examined, understood and dealt with since North America already
has regulatory oversight of hazardous chemicals (even if TSCA is woefully out-of-date).
What was interesting to discover as the conference went on was how difficult
compliance would be for many European and Asian countries. For instance, when
a Russian speaker stated at HCF 2009 that Russia would not comply, he did not
explain the reason, which is quite simple—Russia does not have an agency, or
regulations in place, to ensure compliance. And they are certainly not the only
country. Simply recall the recent issues that China has had with toxic drywall,
tainted milk, etc., and consider the ramifications of accepting large chemical
shipments from a country that is still working through quality control (QC) and
ethics issues. Even with numerous regulatory bodies, the US isn’t without those
issues, as problems can occur in any manufacturing environment, whether deliberate
(as in the case of the salmonella-contaminated peanut butter from a filthy plant)
or not (recent recalls of toxic over-the-counter drugs). Quality and product
safety are not a given—even in companies that spend millions of dollars to ensure
it and in countries that have regulatory agencies to oversee it. Compliance an Ongoing Challenge
ECHA has a big job ahead. Given the lack of regulatory bodies in many countries, the lack of regulations, and the lack of personnel to enforce compliance, ECHA can expect many companies to miss the REACH registration deadlines so that ensuring compliance will be an ongoing challenge.
Knowing that, the agency is making an outstanding effort to help companies meet those deadlines. It has issued a practical guide to compliance with the new CLP requirements. Numerous IT tools have been created to make it easier to register chemicals. A new IT tool for C&L Notification makes it easier to provide the required data. A new REACH-IT 2.0 submission tool is available for bulk submissions. A new Chesar Chemical Safety & Assessment Reporting tool is available (http://chesar.eu). A new IUCLID 5 notification tool with CLP templates, and more IT support for small- and medium-sized enterprises (SMEs) were also introduced at the conference. In addition to several manuals that are available from the ECHA web site, there are numerous webinars that walk the user through the registration process.
Most of these tools are barely out of beta versions, and some of the questions from attendees dealt with software conflicts they encountered trying to use those tools. Workarounds have been created with plug-ins, and version 2.0’s are being rushed out. On the plus side, these tools are almost all created in response to attendee complaints from 2009. Users may encounter error messages and the tools are often not as easy to use as the Internet-savvy world has come to expect, but ECHA has beefed up their staff to be available for support. Because the ECHA team expects a wave of last minute submissions, they have also beefed up their computer systems to cope with the expected deluge.
The subsequent two days were devoted to the HCF forum which covered four key topics: 1) the global challenges of chemicals regulation; 2) chemical policies and emerging economies; 3) financial constraints of competitiveness; and, 4) green chemistry issues.
Chemical Regulations – Global Challenges
Numerous speakers from around the world participated in the discussion concerning global challenges of chemical regulations, providing a look at different regulatory initiatives from around the world and how those tie into REACH. There was a lot of discussion concerning the recent Environment Canada Accord and the Safe Chemicals Act in the US that will replace the outdated TSCA regulation.
E
xecutive Director of CEFIC, Lena Perenius emphasized that “the opportunities
and challenges [of REACH] include modernizing existing chemical regulation, improving
regulatory systems for chemicals, increasing regulatory convergence, and introducing
smart regulations that deliver the desired results in the least burdensome way.
What’s new with REACH is burden of proof/responsibility, and that it doesn’t
differentiate between new and existing substances.”
Confidentiality claims are still a very big issue and there is a draft policy that will be adopted in the near future which will restrict access to substance details. One of the reasons why this area is causing consternation is that ECHA proposes creating a web site that will enable searching on registration information which is expected to contain substance patent details—information that’s typically closely guarded by manufacturers. So the question becomes, who will be doing the searching? Potential customers? Industry watchdogs? Competitors? Hence part of the controversy is over what can actually be gained by making the information publicly available.
Interestingly, perhaps a main competitive force would be Asia since it has already proven so hard to enforce copyrights and patents for other products in those countries. Yet Asian countries have been quite vocal that REACH creates a trade barrier to prevent them from shipping to the EU.
Another constituency are the 1.3 million workers in the EU chemical industry as well as the millions of downstream sectors such as the automobile and textile industries. One of the drivers behind REACH is the affect of chemicals on people in the workplace, where asbestos, lead, benzene, etc. are being used but often not properly disclosed by industry. In this case, it is not competitors who are interested in substance data, but workers, industrial hygienists, the scientific community, inspectorates, poison centers, and public consumers.
In addition, there are challenges for SMEs to meet REACH requirements. Most of the SME member organizations are small, 5-50 employees, and less than $10M in annual revenues, yet SMEs comprise the majority of organizations affected by REACH. They typically have no specific chemical management program established. Language is an issue. REACH-IT is only available in English; even the ECHA home page is only partially available in other languages. Not only is getting chemical safety information to users such as carpenters, painters, glaziers, etc. costly, but getting them to read the information is also difficult. Another challenge is that SMEs are already overburdened with legal obligations and seldom have any scientific background. And in almost all cases, only one person is responsible for REACH, along with a number of other responsibilities.
Despite these challenges, or perhaps because of them, greater awareness of chemical risks and safe management needed to arise. ECHA Director Jukka Malm stated that the key points of a chemical management system req
uired to drive compliance would be provision of (1) information
on substances such as properties and use; (2) hazard assessment; and, (3) risk
management based on a risk assessment. He pointed out that “before REACH only
140 substances were tracked. Downstream users weren’t
even considered, and information was not made available to the public.”
A key concern for ECHA will be enforcement of REACH by member states. In the absence of a regional or national regulatory agency, will enforcement be conducted by local authorities? What different approaches to enforcement are viable? Should fines be imposed and by whom? These and other issues will need to be resolved.
On the plus side, the expected impacts include the disappearance of certain harmful substances from the market and self-regulation. “Registration is a business decision, so some will abandon the market,” predicted Harri Kerminen, CEO of Kemira Oy Ltd. “Self-regulation will occur because business won’t buy from non-compliant companies. This is already happening in Finland and I expect this to happen in the US and elsewhere. In the long run, we expect to see structural changes in the industry. It will no longer a compliance issue but a market access issue.”*
End of Part One. Look for details about the rest of HCF 2010, including the panel discussions on chemical policies in emerging economies, competitiveness and green chemistry in Part Two next month.
* It is important to note that Kerminen does not mean self-regulation with regard to compliance with REACH, but with regard to industry purchase decisions.