CHEMICAL PRODUCT DEVELOPMENT AND DEFENSE

Evaluation, Authorization, and Restriction

Evaluation

Registration dossiers submitted under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) will undergo the following evaluations:

• Compliance Check: A minimum of 5% of all registration dossiers submitted at each tonnage level will be assessed in detail by the European Chemicals Agency (ECHA) to evaluate the quality of the submissions;
  
  
• Dossier Evaluation: For substances registered at higher volumes (i.e., ≥ 100 metric tons), registrants must propose any additional testing to determine the hazard of the substance. ECHA will evaluate all such testing proposals and respond accordingly; and
  
  
• Substance Evaluation: This review will be undertaken by Member State Competent Authorities on those substances that have been prioritized for regulatory action due to their hazardous properties. The evaluation may result in the imposition of restrictions on the manufacture, supply, or use of the substance, changes to the substance’s classification and labeling, or addition of the substance to the priority list for authorization.

In addition, all registration dossiers will undergo an automated completeness check to determine that all relevant sections are complete, but this check by ECHA will not assess the quality or the suitability of the information.

Authorization

Under the REACH authorization provisions, “substances of very high concern” (SVHC) will be included on a list of candidate chemicals that ECHA is expected to publish in late 2008. Eventually, approximately 1,500 SVHCs are expected to be taken from the candidate list and included in REACH Annex XIV, the list of substances that will be subject to authorization. Once included in Annex XIV, authorization from the European Commission will be needed before the substance can be marketed or used.
SVHCs include:

• Category 1 or 2 carcinogens, mutagens, and reproductive toxins (CMR);
  
  
• Persistent, bioaccumulative, and toxic substances (PBT);
  
  
• Very persistent and very bioaccumulative substances (vPvB); and
  
  
• Substances, identified on a case-by-case basis, for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern (e.g., endocrine disruptors).

There is no volumetric threshold for a substance to be subject to authorization, and companies should keep in mind that the REACH authorization scheme is explicitly geared towards progressive replacement (i.e., substitution) of SVHCs.

Restriction

Any substance that poses a particular threat can be restricted under REACH, with the restriction(s) serving as a “safety net” to manage risks that are not addressed by the other REACH processes. A substance can be subject to restriction(s) if it is demonstrated that risks need to be addressed on a Community-wide basis, and the restriction(s) may apply to all uses or to specific uses.

As with authorization, there is no volumetric threshold for a substance to be subject to restriction. Proposals for restrictions will be prepared by Member States or by ECHA.