REACHing for Answers
Much remains misunderstood about complying with European chemical regulation
- By Will Schreiber
- Jun 03, 2009
On the first of June 2008, the newly established European Chemicals Agency (ECHA) opened its doors in accordance with the European Community’s landmark chemical management regime enacted by the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation (EC No. 1907/2006). From that date producers and handlers of all types of chemicals, whether they were on their own or embodied within "articles" they supplied, have had specific obligations to fulfill to the ECHA and their European customers.
The effects of REACH have spread throughout supply-bases, just as ripples in a pond extend outwards from where a rock has landed. On the one hand, this means that information and requirements have extended far beyond the actual legally obligated parties, but on the other, it means that the information becomes increasingly misunderstood; leaving the policies and declarations made by companies inappropriate in the context of what is actually required.
Although REACH principally targets the chemicals industry, the framers of its provisions intended that the effects of chemicals be controlled throughout their lifespan. As chemicals make up virtually every product humanity consumes, everyone, from the chemical manufacturer to retailers of finished goods, have obligations to inform those who buy their products if there are any substances of very high concern (SVHC) included within their product.
The notion of consumer notification is not obscure or unrelated to chemical management. In fact, it should be expected that the manufacturer of a product should be able to tell you, the consumer, whether or not there is anything harmful within in it, should they not?
While we could write a whole book on the nature and requirements of REACH, and some people have, it is this particular requirement, the obligation to notify customers of SVHC in their products, that has caused the greatest impact within supply-chains recently.
There are three issues that have caused supply bases the greatest problems in adopting a REACH compliance strategy and management system:
- there is uncertainty regarding who is legally responsible for providing information about SVHC presence;
- how an SVHC is classified and what communication must follow as a result of it; and
- how reporting of SVHCs is to take place within the supply-chain. Each of these presents complex questions that organizations must address and failure at any particular junction throws your entire system into jeopardy. Looking at these specific questions in isolation, however, shows us that these are not insurmountable problems, they just require a little bit of knowledge to answer.
Who is responsible?
Any business that has operations within the European Union or Norway has direct legal responsibilities under REACH. This could be in the form of completing full registration dossiers, because of the importation of substances or preparations (e.g. resins, bonding agents, etc.), communicating the presence of SVHC in the articles "supplied" to another party, or simply ensuring that workers are informed of any dangerous substances they are coming in contact with and have access to up-to-date Safety Data Sheets. Unfortunately, many organizations do not look at their own liability as European entities and view REACH only in the context of what their customers require; which for most organizations is just the disclosure of SVHC.
The electronics industry in particular has had great difficulty complying with this requirement due to legacy understandings of responsibility under the Restriction of Hazardous Substances (RoHS) Directive (Directive 2002/95/EC) where the ‘brand holder’ was ultimately responsible. REACH applies to all organizations, regardless of where they are in the supply-chain, so information must be passed on between organizations in accordance with REACH, and manufacturers may not charge their customers for the data collection, management, or disclosure of SVHC.
What do I look for?
Identifying and collecting data on chemicals within products takes time and resources. The more complex the product, the greater the information collection challenge will be. For instance, a table has relatively few chemicals present in the final product compared to electronics equipment where a small USB memory stick can have as many as 300 different chemicals.
Although many trade organizations (e.g. ETUC Priority List), industry groups (e.g. Joint Industry Guide Ed. 2.0), and nongovernmental organizations (e.g. Substitute It Now (SIN) List 1.0) have produced their own "substances of concern" lists to help businesses identify where they should focus their efforts, the only list that requires organisational compliance is the confusingly named REACH "Candidate List." The "candidate" refers to the substances placed on the list being candidates for the Authorization requirement of REACH, not their status as being classified an SVHC. Despite expecting not to have the first SVHC list, which is revised continuously, until early 2009, the ECHA published its initial list in October 2008.
The groups named above have created their own lists as a way to ensure that once a substance is added to the SVHC List, their obligations to transfer information are immediate and "automatic" to their customers. The ECHA has also implemented a system to help companies prepare by launching a "Registry of Intentions" that shows what substances are currently under SVHC classification review.
How do I report?
Despite the Guidance on Articles being published in May 2008, just weeks before ECHA opened its doors, the definition of "article" is still misunderstood. For the sake of simplicity, all products and packaging components should be regarded as articles. An article, in the context of REACH, is anything that is not a chemical or preparation; in fact, the moment the chemical properties of a product are less important than its function, you have an article.
SVHC reporting, for better or worse, is not confined to a single process. Every company can conduct reporting differently, but the criteria that triggers when a communication to customers is required remains static: an SVHC must be present in any article you supply (e.g. single packaging component, computer, a/c adaptor, etc.) to another party in Europe where its concentration in that article is greater than 0.1 percent weight by article weight ... although even this threshold is currently being reviewed by the ECHA since six European Member States formally disagreed with this standard and believe it should be at a lower level. If the threshold is breached, the SVHC must be communicated "automatically" to any professional customer (e.g. OEM, distributor, retailer, etc.) or upon request by a European consumer within 45-days. This obligation is part of the REACH regime, but there is no "REACH compliant" product, only REACH compliant systems that are capable of fulfilling the applicable requirements.
Global industry has moved ahead in many ways since the ECHA began operations last year. Implementing strategies and communicating substance risks are only part of the much larger and complicated requirements REACH places on industry. Every manufacturer should be aware of their liabilities and have an understanding of the REACH requirements in order to benefit from its intended purpose. These benefits will come at a cost and during the economic problems of the world right now, your organization may struggle to justify new management expenditure. Nevertheless, as the European Commissioner for the Environment Stavros Dimas said at the second stakeholder day in May 2009, "if we apply environmental and health principles cleverly, innovation will follow naturally. And competitiveness will increase. The two go hand-in-hand."
Will Schreiber, AIEMA, is principal consultant – Regulatory Compliance and Sustainability at Foresite Systems' United Kingdom office.