IPC compares ROHS to REACH.

Dealing with the devil: Could REACH be better than ROHS?Y;

IPC compares ROHS to REACH.{W
http://www.edn.com/article/CA6 ... 79429

By Fern Abrams, IPC -- Electronic Business, 2/5/2008

It’s not clear what the right metaphor is for choosing between regulation under Restriction on Hazardous Substances (ROHS) or REACH (Registration, Evaluation and Authorization of Chemicals) … Is advocating REACH over ROHS akin to “Dealing with the Devil?” or is it more like “the enemy of your enemy is your best friend?” Or has IPC, in advocating regulation under REACH over ROHS, failed to heed the old adage, “Better the devil you know than the devil you don’t?”

In IPC’s January comments to the European Union (EU) Commission on their review of the ROHS regulation, IPC urged the commission not to expand the scope of ROHS by restricting additional substances. IPC also said that if the Commission deemed additional substance bans to be absolutely necessary, a full life-cycle assessment of the substance and its substitutes should be conducted in order to ensure that the substitution does not have unintended adverse environmental and human health impacts.

IPC went on to say that any further substance restrictions beyond ROHS would more appropriately be addressed under the REACH legislation to avoid unnecessary confusion and regulatory overlaps. This might seem to be flirting with disaster, but let’s look a little closer.

Yes, REACH is big, complex and likely to be very costly for the industry. The regulations themselves are hundreds of pages long, before you even get to the guidance. But perhaps there is something to be said for complexity. After all, the ROHS regulation was brief and to the point. So brief that it left many wondering what it required and how to implement it. Even the process for conducting a ROHS review merited only five sentences in the ROHS directive. While the ROHS directive calls for a review of the scope, substances and exemptions under ROHS, no detail is provided as to how the review should be carried out, how stakeholder input should be sought, how substances should be selected, etc.

To a large extent, the ROHS regulation is a European black box: Start with the periodic table, throw in some political aspirations, season liberally with environmentalist positions, and maybe, just maybe, add a dash of science. Shake it all up, and see what sort of regulations fall out.

REACH, on the other hand, spells everything out. We may not like the process, but at least there is a process. The REACH legislation entered into force on June 1, 2007 to streamline and improve the former legislative framework for chemicals in the EU. Under REACH, substances produced or imported in quantities of one ton or more per year, per company, must be registered by manufacturers and importers. As part of the registration dossier, manufacturers and importers must demonstrate that they have identified and managed risks linked to the substances they manufacture and market. Part of this identification and management process includes assessing downstream use of the substances, such as the use of solder flux in the assembly of electronics. Based on dossier information, authorities may also select substances for a broader substance evaluation to further investigate substances of concern. The evaluations will be based on hazard and risk characterizations provided by the manufacturer or importer. A key difference between REACH and ROHS is that ROHS does not have any specific data requirements for evaluation of substances. The development of the existing ROHS substance restrictions did not rely on data at all and certainly did not consider whether there would be exposure of people or the environment to the hazardous substances used in electronics.

Under REACH, any substance determined to be a Substance of Very High Concern (SVHC) may not be put into products unless they are granted authorization. This is similar to the ROHS requirements that restricted substances not be used unless granted an exemption.
Under REACH, SVHCs will include substances which are:

• Carcinogenic, mutagenic or toxic to reproduction (CMR) classified in category 1 or 2,
• Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH legislation, and/or
• Identified on a case-by-case basis from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above, e.g. endocrine disrupters.

Once a candidate list of substances requiring authorization is developed and prioritized, manufacturers wishing to import, sell or use (in their product) a substance from the candidate list will be required to apply for authorization. Each downstream manufacturing use of a listed chemical must be separately authorized. Authorization applications will need to include a chemical safety report, covering risks related to those properties that caused the substance to be included in the authorization system and an analysis of possible alternative substances or technologies. Under REACH, the suitability of available alternatives will be assessed taking into account all relevant aspects, including whether the alternative results in a reduction of overall risks and is technically and economically feasible.

Authorizations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. The “adequate control route” does not apply for substances for which it is not possible to determine thresholds and substances with PBT or vPvB properties. If the risk is not adequately controlled, an authorization may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies.

As you can see from this 10,000-foot summary, REACH is complicated. There are a lot of steps. The process is far from foolproof and is certainly open to influence, interpretation and opinion. Clearly, REACH is not a model regulation that IPC would like to see replicated. But, from a REACH vs. ROHS process, substances in the REACH process will not be banned without careful consideration of the full societal impact, which is more than can be said of ROHS.