REACH: Industry Prepares for Another EU Regulatory Tidal Wave - Online Exclusives

The European Union Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Directive will have a far-reaching effect on anyone who buys, sells or uses chemicals. While the bulk of the regulatory requirements are aimed at those manufacturing or importing chemicals (referred to as substances under REACH) into the EU, all companies that use chemicals or make products that contain chemicals will be affected. Key issues for manufacturers of articles are the requirements to provide information to their suppliers and customers, regulatory notification requirements for products containing especially hazardous chemicals (known as substances of very high concern or SVHC), bans of some SVHC substances, and potential withdrawal of chemicals from the marketplace if suppliers choose not to complete the REACH registration processes.

Manufacturers of preparations, which are mixtures of substances, may have additional responsibilities if their suppliers do not register the substances for their specific uses. Many guidance documents are still being written and the first candidates for the SVHC list have just been released. Additionally, because of intellectual property concerns and lack of regulatory clarity, many suppliers are reluctant to discuss their REACH compliance plans. Therefore, it is somewhat difficult to fully predict the impact of the regulation, but it will be significant.

Under REACH, substances produced or imported in quantities of 1 ton or more per year, per company, must be registered by manufacturers and importers. The pre-registration period began June 1, 2007, and ends December 1, 2008. Substances that are not pre-registered will not be able to participate in the 10-year phase-in, but will be subject to registration immediately. 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, including an assessment of the downstream use of the substances, such as the use of adhesives 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.

Under REACH, any substance determined to be an SVHC may not be put into products unless it is granted authorization. REACH specifies that SVHCs include substances that 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 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.

On June 30, 2008, the European Chemicals Agency (ECHA) issued for consultation its first set of candidates for evaluation. Following are the 16 substances nominated for inclusion on the candidate list.

Anthracene
4,4’-diaminodiphenylmethane
Dibutyl phthalate
Benzyl butyl phthalate
Cyclododecane
Cobalt dichloride
Diarsenic pentoxide
Diarsenic trioxide
Sodium dichromate, dehydrate
Musk xylene
Bis (2-ethyl(hexyl)phthalate
Hexabromocyclododecane
C10-C13 chlorinated paraffins
Bis (tributyltin) oxide
Lead hydrogen arsenate
Triethyl arsenate

After taking comments on the candidates, the ECHA Member State Committee will vote on the final list in October. ECHA will then prioritize substances from the list to be subject to authorization. Once the list of substances requiring authorization is developed and prioritized, manufacturers wishing to import, sell or use (in their product) a substance from that list will be required to apply for authorization. This is only the beginning; new candidates will be added periodically to the list until all substances of concern have been reviewed.

Each downstream manufacturing use of a listed chemical must be authorized separately. 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. 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.

REACH promises to have a significant impact on industry for years to come. Companies must take time now to evaluate the impact REACH will have on them. A good starting point is the ECHA website, echa.europa.eu/reach_en.asp. Although the regulations will be phased in over the next 10 years, the pre-registration period ends December 1, 2008, so it’s important for companies to begin preparing for the first wave to hit, if they haven’t already.