Article Index

Calendar

CD's
- Cost Justification CD
- LIMS Primer CD

Email Newsletter

Featured Article

Guest Book

Industry News

Introduction to LIMS

LIMS Products & Services

LIMSource

Reprints

Helsinki Chemicals Forum Highlights ECHA and REACH Regulation Challenges
by Helen Gillespie, Editor, LIMS/Letter

Launching a new standard is never easy. Despite an agency’s best efforts, phrases will be ambiguous and easily misinterpreted, deadlines will be difficult to meet, unforeseen obstacles will occur. This has been the case with one of the latest European Commission (EC) chemical safety regulations known as Registration, Evaluation, Authorization and Restriction of
Chemicals (REACH).

Started with the best intentions of consolidating disparate regulations under a single standard and streamlining cumbersome processes, REACH was adopted into law on June 1, 2007 with a ten-year phase-in plan expected to result in a unified, European Union (EU)-wide policy for chemicals regulation. The goal is to simplify and facilitate trade of chemicals and chemical-containing products between EU member countries, and is estimated to affect some 50,000 substances. Yet because REACH affects all organizations that ship chemicals in excess of 1 ton into the EU, it is also expected to impact companies worldwide that export chemicals or chemical-containing products to the EU. Of particular interest is a list of “substances of very high concern”, as products containing these substances may face rejection from European markets.

As part of the initiative, REACH established the European Chemicals Agency (ECHA) to manage implementation of the regulation. As part of this charter, ECHA hosted the first Helsinki Chemicals Forum (HCF) from May 27-29, 2009 at the Helsinki Exhibition & Convention Centre in Helsinki, Finland, preceding the conference with a Stakeholders Day that invited public comment.

REACH Dominates Conference

The HCF covered many key issues, although REACH was the dominating topic throughout. In particular, the Stakeholder’s Day – which was attended by EU representatives from almost every country – brought up a number of critical issues, ranging from interpretation of the regulation to compliance challenges.

The conference delivered a comprehensive and glittering set of more than 40 erudite speakers from around the world representing not only top industry and government officials, but various chemical councils and regulatory boards. Panels were provided for each of the four key areas identified by ECHA, including: Competitiveness & Innovation; Chemical Industry Regulation; Safety & Sustainability; and, Chemistry & Consumers. After the opening ceremonies, the HCF quickly leapt into an in-depth discussion of the REACH regulation.

“REACH was the answer to the need to close the serious knowledge gap that existed under the previous legislation. We had very little information about more than 100,000 chemical substances in use. Most of these had never been tested. The "burden of proof" to ensure that chemicals are safe previously fell on the authorities. REACH now places this responsibility on industry,” explained Mr. Stavros Dimas, Commissioner for the Environment, EU Commission.

Attendee comment was invited throughout, with many questions from the audience during the panel discussions addressing key elements of the standard from compliance to enforcement.

Overwhelming Response

From the start ECHA included stakeholders in the standard’s development to ensure a climate of transparency and consultation. Extensive dialogue occurred with stakeholders before and after the original proposal was presented, resulting in more than 6,000 stakeholder responses. Even so, the full impact of the regulation was not foreseen. When the opportunity to pre-register substances during a phase-in stage in December 2008 was offered, instead of some 25,000 expected registrations, ECHA received in excess of 2,800,000 registrations within 24 hours of the program’s introduction, greatly overwhelming their ability to respond to the registrations appropriately. “No one had dreamed of that,” stated Dr. Erwin Annys of the European Chemical Industry Council. The agency was buried under multiple registrations as well as registrations by number of companies that are not expected to participate in the final registration process. “The first challenge is to organize all the data,” Dimas confirmed.

Another unanticipated challenge implementing REACH has been the difficulty determining lead registrants for a substance. Because more than one organization manufactures the same substance, it made logistical sense to organize manufacturers into Substance Information Exchange Forums (SIEF) to align all registration and testing activities for a particular substance. SEIFs would assign a lead registrant to be responsible for managing the Forum’s activities. However, no unique mechanism was devised for the SEIF lead registrant to communicate with ECHA, hence one of the HCF goals was to publicize the need for SEIF leads to announce themselves to ECHA to streamline the registration process.

In addition, it was hoped that the December 2008 pre-registration program would also identify lead registrants for particular substances. This did not occur. Instead multiple registrations were received for the same substance, and lead registrants – when identified – have not always remained the lead for a variety of reasons. The original estimate of 50,000 affected substances appears to have been underestimated, but even this is not clear due to the multiple registrations received. As a result, one of the key stakeholder concerns voiced during HCF was ECHA’s ability to manage the registrations. Stakeholders pointed out the tendency for organizations to wait until a deadline to perform a task, and believe that the vast majority of registrations will occur in the month before the registration deadline, thus overwhelming ECHA with a mountain of paperwork.

According to Dimas, “we are now in the second phase and companies manufacturing the same substance must share the information they have with fellow producers [through the SEIF process]. In the light of the high number of pre-registrations received, this has turned out to be a challenge for all participants, be they small specialized companies or large multinational producers. However, I am pleased to see how industry, ECHA and the Commission have responded to the difficulties that were signaled. It is industry that is driving and guiding this process and a number of support systems have been established.”

“The first registration deadline – November 2010 – is just around the corner,” Dimas points out. “These are serious challenges, but we count on industry’s expertise, networks, and innovative spirit to face them and to find solutions to comply with the regulation.”

Documentation Requirements

REACH requires submission of a dossier about each substance for registration. Documentation concerning the substance must include not only guidance on its safe use and exposure information, but also the exact identity of the substance which includes physiochemical, toxicological and ecotoxicological information. Providing this information has many organizations in an uproar since such detail often includes proprietary information and there is great concern about the safeguards used to keep such information secure.

Ambiguous Phrases

Another of the challenges regarding REACH is knowing which substances and intermediates fall within its scope and which do not. According to ECHA’s “Guidance in a Nutshell”, “the basic definition of a substance is a very broad one which includes not only potentially hazardous industrial chemicals, but every type of chemical substance manufactured in or imported into the EEA. It therefore also includes substances which are already closely regulated by other legislation or which typically cause no or only minimal risk to human health and the environment. For these and other reasons there are some complete or partial exemptions from REACH requirements, e.g. for: radioactive substances; intermediates; waste; substances used in medicinal products, … food, etc.”1

The regulation states which substances apply and which do not, but because the organization is at risk for having products refused for import, all levels of management – including the legal department – should be intimately involved in the initial registration process to ensure coverage of and documentation for applicable substances.

What’s not ambiguous is the title of the regulation’s Chapter II, Title I, Article 5, “No data, No market”, and its content which states “substances on their own, in preparations or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.”2 Thus, without the required documentation, product will be refused entry. How this will sit. for instance, with Russia – represented by panelist Mr. Dmitry Skoblev, VNICSMV, who implied that it will be impossible for the country to meet the requirement by the specified deadline – will be interesting to watch.

Ability to Comply

In truth, most manufacturers are probably already addressing 90 percent of the REACH requirements, with the remaining percentage essentially consisting of addressing the reporting requirements of the new standard. There was much complaint during HCF that this was just one more regulation that required reporting essentially the same information already being reported in another form to another agency. Having said that, with today’s electronic data management solutions, technically (once the requirements are clearly understood) REACH is just another reporting requirement and as such the data can be automatically compiled into a REACH report as other data is compiled into other regulatory reports.

Affect on the Laboratory

How will this new standard affect the laboratory? While the focus is on the chemical composition of materials being shipped into the EU, and the organization’s Manufacturing Execution System (MES) or Production Execution System (PES) will need to provide that information with shipping manifests in a way compatible with REACH requirements, it is the lab that will need to ensure that the correct information is provided. Again, the problem is understanding exactly what data needs to be reported and how it should be presented. Fortunately, there are a number of data management solutions providers ready to help deal with these issues.

SAP, for example, has a key stake in ensuring that their customers can address the new requirement since their data management solutions are directly involved in the final manufacturing processes. They provide numerous business briefs and white papers on the subject, including a very succinct white paper entitled “REACH Compliance” that provides insights into implementation at http://www.SAP.com.

The Helsinki Chemicals Forum is organized by the Chemicals Forum Association in cooperation with the EU Commission and ECHA, with partners that include the Ministry for Foreign Affairs of Finland, the City of Helsinki, Greater Helsinki Promotion Ltd, the Chemical Industry Federation of Finland and the University of Helsinki. It will be held again from May 20-21, 2010 in Helsinki, Finland.
This is the first of a series of articles that will explore the impact of the REACH standard. For more information about the REACH standard, please visit http://www.echa.europa.eu.


References

1. European Chemical Agency (ECHA), Guidance in a Nutshell, http://echa.europa.eu, © 2009, Page 7
2. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 © December 2006, Chapter II, Title I, Article 5, Page 20