Find out what it takes to apply for substance authorization under REACH. Get insight into the committee’s opinions and find out about important dates to remember.
ECHA have conducted an analysis of what is confidential business information and what can be publically disseminated which is presented below:
- A brief description of the use of the substance, the conditions of use and the use descriptors
- The exposure scenarios
- The analysis of alternatives
- A non-confidential summary of the substitution plan
- A non-confidential summary of the Socio-economic analysis
- The Applicant’s name
It is unlikely that there will be any consultation with the applicant concerning which information will be disseminated; however ECHA will only publish information which is obviously non-confidential.
The following details from the RAC and SEAC opinions will be published on the ECHA website once they are adopted by the commission:
- The overall final opinion along with the justification
- Any additional risk management or monitoring measures considered by the ECHA committees
- The duration of any review period
- The substance specific details including identity and a brief description of uses
- Administrative details concerning the application including the identity of the rapporteurs and relevant timelines as set out in the legislation.
- The Applicant’s name
Applicants for Authorization should ensure that they have clearly flagged confidential information in their IUCLID dossier. This is important as Third Party representation for Authorization is not one of the permitted functions under Article 4 of the Regulation and any Applications for use of Annex XIV substances will be clearly linked to the applicant.
Decision criteria for Authorization Application
The Authorization process poses a fundamental business question which extends beyond the laboratory, occupational hygienist or Environment, Health and Safety Department:
What will be the impact on my business if the substance can no longer be used in the EU?
Once a substance is listed on Annex XIV, the intention is that its use will be eventually discontinued and replaced with safer alternatives. There are several different avenues open to companies currently using Annex XIV substances, each of which will have multiple associated drawbacks or benefits to the business.
Examples of options open to companies include:
- Substituting substances
- Adapting technologies and processes to remove the need for the substance
- Changing the product specification to exclude the substance or simply stopping the product line.
The impact of the route taken will be multifactorial but could:
- Result in a change in the technical performance of the product
- Affect the efficiency of the process or its resource requirements
- Affect the quality or aesthetics of the product.
The overall result could affect the costs associated with the product/process and in turn company revenues and profits. The impact upon the commercial performance of the company may affect its competitive position, investment and employment opportunities.
These are core business issues involving commercial, technical and strategic planning and not just related to environmental or health and safety concerns.
In deciding whether to apply for an authorization a risk/benefit analysis needs to be conducted.
The benefits may include:
- avoidance of cost increases/ reduction in profits
- avoid reductions in economic performance, employment and investment opportunities
- avoid increased environmental impacts such as energy use or transport
The risks assessed are the health and environmental impacts of continuing to use the Annex XIV substance. These of course may be mitigated or even reduced to zero by implementation of adequate controls.
If it can be demonstrated that benefits outweigh the current risks, this will more likely result in authorization. Simpler, clearer cases will also more likely result in Authorization, for example if a low risk to the environment can be demonstrated in conjunction with higher costs associated with alternatives.
In the following cases Authorization is unlikely to be granted and application costs may be saved:
- The existing health and environmental risks outweigh the economic benefits, especially where adequate control cannot be demonstrated, such as widespread and dispersive use in the environment.
- Viable alternatives, either substances or processes, have been identified.
In conducting the pre-Authorization analysis it is recommended that you consider the headings outlined in the Authorization templates available from the ECHA website: http://echa.europa.eu/web/guest/applying-for-authorisation
If these are completed correctly and you conclude that Authorization is appropriate then it is likely that the RAC and SEAC may agree with you. However you will also need to consider the additional costs and resources required to prepare the authorization application and remit the application fee as part of the commercial justification. All of this is on the proviso that Authorizations are only temporary permissions which need to be re-applied for with the associated justifications and costs each time.
Applying for Authorization
Applying for Authorizations is a new process, both for Industry and ECHA. This has been foreseen by ECHA and a number of supports are being put in place including extensive guidance documents on the website: http://echa.europa.eu/web/guest/applying-for-authorisation and planned briefing sessions for potential Applicants in October 2012 (details to follow).
There are three main decisions to make when preparing an Authorization application:
- Which uses of the substances you want to support in your application
- Whether the application will be prepared individually or as a joint venture and if so which parts?
- Whether to apply by the Controlled Conditions or Socio-economic Assessment Route
Taking each of these points in turn, we will consider Application for Uses first; in deciding which uses to apply the following factors can be considered:
- Are alternatives readily available and do they provide the same functionality/properties
- Are the alternatives economically feasible
- Do the alternatives present lower hazards/risks
- Are the alternatives sustainable, either economically or from a regulatory perspective i.e will they too be subject to Risk Management measures in future?
Once the uses being applied for have been decided then the broad description of uses needs to be defined. The description of use will be publically disseminated so the level of detail contained in the Use needs to balance confidential business information with the objective of gathering useful information from the public consultation.
Secondly, is it feasible to make a joint application for Authorization with other companies?
This will need to be assessed on a case by case basis; for the analysis of alternatives there will often be a large amount of similarity between companies and their uses, as there will be with identifying safe levels of use for Substances with threshold effects. Whereas Socio-economic analysis and substitution plans will more likely be dependent upon companies’ individual technical and commercial strategies.
Reaching agreement on those parts of the application which can be submitted jointly, such as an analysis of alternatives per use, or a comparative socio-economic analysis could significantly reduce the resources needed for the task.
The third decision, but perhaps the most important is deciding which route of Application to progress, either the Adequate Control or the Socio-Economic Analysis route. This is determined by the intrinsic hazards of the substance. If the substance is a threshold CMR then the adequate control route can be used for applying for the Authorisation. If the risks presented by such as substance cannot be adequately controlled, or the substance is a non-threshold carcinogen or environmental toxin then the socio-economic route must be followed. That involves an assessment of alternatives followed by a risk benefit analysis. If alternatives are available or the risks outweigh the benefits then the Authorisation will be declined.
The decision to define a substance as having threshold or non-threshold effects must be scientifically justified and will be subject to scrutiny by the RAC.
Dates to remember
Finally, it is advised that the applications for Authorization are prepared with the following “windows of Application” in mind. These have been suggested by ECHA as the optimum periods within which to submit the application to ensure the application is processed efficiently by the committees:
20 August – 3 September 2012
19 November – 3 December 2012 (last submission for musk xylene and MDA)
15 February – 1 March 2013
20 May – 3 June 2013 (last submission for DEHP, BBP, DBP and DIBP)
19 August – 2 September 2013 (last submission for diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulfochromate yellow (C.I. pigment yellow 34) and lead chromate molybdate sulphate red (C.I. pigment red 104))
18 November – 2 December 2013 (last submission for HBCDD, TCEP and 2,4-Dinitrotoluene)
[button color=”#5879a6″ button link=”http://www.h2compliance.com/free-30-minute-consultation/” ]Free 30 Minute Consultation[/button]