REACH is a set of regulations on the safe use of chemicals adopted in 2006 by the European Union. A four-part series on REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) compliance in Plastics News began with an article on registration [“REACH compliance explained,” PN, March 23, Page 6] and continued with an article on the identification of substances of very high concern (SVHCs) and authorization [“REACH: classified substances,” PN, April 20, Page 6]. This article, part three of the series, delves into how companies will need to manage authorizations for and restrictions on substances. A future article — the last in the series — will cover current issues in substance information exchange forums (SIEFs) and consortia of particular relevance to the plastics industry.
July 17, 2009) — Once a substance is placed in Annex XIV (substances subject to authorization), in most instances parties will need to apply for authorization to use the substance.
Unlike registration, there is no tonnage threshold for a substance to be subject to authorization. The authorization application must be submitted 18 months (or earlier, if specified) before the “sunset date” of the substance.
The ultimate goal of the authorization process is to incite the industry to find substitutes for the SVHCs it is currently using.
While the European Commission may grant an application for authorization, it is likely that significant pressure from non-governmental organizations (NGOs), governments and distributors of consumer goods will require companies to re-evaluate the benefits of certain substances and their presence in products.
Who can submit an application?
Manufacturers, importers and/ or downstream users can submit applications.
If a downstream user does not apply for authorization, it must purchase the substance from a company that has been granted authorization for the specific use by the downstream user.
The downstream user must apply the conditions of the specific authorization and it must notify the European Chemicals Agency (ECHA) that it is using an authorized substance.
What goes into an application?
Applications for authorization must include:
* A chemical safety report (CSR) covering risks related to the properties that caused the substance to be included in the authorization procedure (unless already submitted as part of the registration).
* An analysis of possible alternative substances or technologies. If the analysis of alternatives reveals that there is a suitable alternative, the applicant must submit a substitution plan, explaining how the substance will be replaced with the alternative.
* An applicant may include a socioeconomic analysis of the substance, but in cases where the applicant is unable to demonstrate adequate control of risks and where no suitable alternative exists, it must include such an analysis.
Will “third parties” get involved in this process?
Yes. The ECHA will make available on its Web site information on uses for which applications have been received and reviews of authorization.
Interested third parties — which include NGOs, other companies, international organizations and non-EU countries — will be permitted to submit information on alternative substances or technologies.
In today's markets, where sensitivities to environmental and health impacts run high — and campaigns target products that allegedly expose consumers to unwanted risks — companies must deal not only with formal regulatory requirements, but also must protect their markets by adequate and appropriate communications throughout the supply chain.
When will an authorization be granted?
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 (persistent, bioaccumulative and toxic) or vPvB (very persistent very bioaccumulative) properties. If the risk is not adequately controlled, an authorization may still be granted if it is proven that the socioeconomic benefits outweigh the risks and there are no suitable alternatives.
Do I have to label my product in a particular way?
Yes. Holders of an authorization, as well as downstream users including the authorized substance in a preparation, must include the authorization number on the label before they place the substance or preparation containing the substance on the market for an authorized use.
What do I need to know about restrictions?
Any substance on its own, in a preparation or in an article, may be subject to restrictions. The restriction can apply to all or specific uses, and there is no tonnage threshold.
If a use is not specifically restricted, then it is allowed— unless the use is subject to authorization, other EU legislation or national legislation.
Again, interested parties, including NGOs, will have an opportunity to comment on any restrictions proposed by the ECHA.
Russotto, former executive director of Brussels-based PlasticsEurope, is a European affairs adviser in the Brussels office of the international law firm Steptoe & Johnson LLP. Atlee is a Brussels-based associate with the firm.