In the following article, we will be sharing our experience, in order to identify the challenges met by the industrials in the field.
Reminder: REACH Authorisation
The Authorisation procedure is one of the chemical risk management options established by the REACH regulation at European scale.
It applies to substances identified as SVHC (“Substances of Very High Concern”) and deemed to pose a serious threat to human health or environment:
- CMR 1A and 1B : carcinogenic, mutagenic or toxic to reproduction
- PBT : persistent, bioaccumulative and toxic
- vBvP: very persistent and very bioaccumulative
- substance of equivalent concern, e.g. endocrine disruptors or respiratory sensitisers
The substances included in Annex XIV of REACH are subject to Authorisation and are due to have their use forbidden in the European Union within a short-term period (36 to 48 months after inclusion). A REACH Authorisation is a temporary exemption for a substance and a specific use. Three exemption durations (“revision period”) are generally considered: 4, 7 or 12 years.
Producing an application for authorisation under REACH requires to characterise the risk generated by the use of the substance (Chemical Safety Report), to present in detail the potential alternatives to the substance as well as the substitution strategy (Analysis of Alternatives) and finally to carry out a comparative impact assessment of a continued use of the substance and its withdrawal (Socio-Economic Analysis).
A set of specific characteristics from the Aeronautics and defence sector must be taken into account when constituting an authorisation dossier, in particular: sovereignty issues, confidentiality issues, performance requirements, long development and qualification durations as well as long lifespan of equipment.
Specific points in the Aeronautics and defence sector
Confidentiality issues are at the centre of an application for authorisation’s constitution
Confidentiality matters are at the heart of the defence industry. In the context of an application for Authorisation, several points are to be taken into consideration:
- Define in detail the scope of the process description in the Chemical Safety Report, focused on the potential exposures to the substance, so as to not disclose sensitive information such as specific process parameters or know-how elements, which could give a competitive edge to a competitor.
- Throughout the project, identify the sensitive data regarding the description of research works for the substitution in the Alternatives Analysis.
- Adapt the level of detail provided in the impact assessment for the applicant in the context of the “non-use” scenario (loss of income, investment and jobs) in order to meet ECHA’s requirements while protecting sensitive data for the Socio-Economic Analysis.
Confidential data protection mechanisms exist and offer, in particular, the possibility to produce a confidential version of the documents (containing all data required for the dossier assessment by ECHA’s expert committees); sensitive data can be excluded from the publicly-disclosed version of the documents.
However, these mechanisms are limited to economic sensitivity: ECHA can’t protect defence-sensitive data such as the number of equipment in operation, exact levels of performance, specific characteristics of the concerned equipment, etc. Military-sensitive data must not be mentioned in the application for authorisation .
In general, it is possible to make a case for authorisation without providing any defence-sensitive data. Data that is confidential for economic reasons can be blanked out from the publicly-disclosed version of the documents.
The critical performance requirements for aeronautics and defence equipment
Aeronautics and defence equipment are subjected to major performance requirement in order to ensure their correct functioning in severe operating conditions. Said equipment is subject to long-term development cycles (several decades) and extremely strict qualification processes regulating their industrialisation and operational deployment.
In case an alternative is identified, any substance or process substitution must meet the initial requirement level and be submitted to a partial or total requalification process of the equipment. As a consequence, the duration or revision period required for applications for authorisation in the aeronautics or defence sectors can be relatively long, compared to other sectors with lesser qualification imperatives. In order to justify these durations, it will be necessary to provide a precise description of the qualification framework of the application and, if possible, to justify this duration on the basis of actual feedback from past experience.
The involvement of customers and final users of equipment makes for an interesting contribution to the application for Authorisation, since it provides external information to ECHA’s experts.
The justification for the duration of the review period constitutes a key element of an application for Authorisation, especially in the defence sector where the duration of the qualification procedures can be long, compared to other industrial sectors.
The challenge in maintaining equipment with a very long life span in operational conditions
Aeronautics and defence equipment generally have an operational life span of several decades. Such long life spans require operational condition maintenance and therefore the supply of spare and replacement parts throughout this period.
In the context of an application for Authorisation, the “standard” review period duration doesn’t correspond to these long-term imperatives. To deal with this issue, the REACH regulation includes the possibility of renewing the Authorisation at the end of the review period. In addition, in most cases, production of parts for maintenance purposes doesn’t constitute the main activity of the company submitting the application for Authorisation; the quantity of substances used can therefore be limited.
PTo answer this twofold issue, reflections are taking place at ECHA to simplify the Authorisation process for two cases:
- Small volumes of substance used (<100kg/year)
- Replacement parts
The implementation of these simplified processes was planned for 2016, but no decision has yet been validated.
The integration of specificities related to the production of replacement parts is being taken into account by ECHA.
At the heart of Authorisation Applications: issues on sovereignty and/or operational capacity of armed forces
The Socio-economic Analysis aims at showing that the impacts of the continued use of the substance exceed those of its prohibition. This demonstration is partly based on a monetary assessment of the costs generated by these two scenarios.
For the defence sector, fundamental issues on sovereignty and operational capacity are generally at play with the Authorisation procedure. Such issues cannot usually be characterised by a quantitative monetary evaluation, but will be taken into account by ECHA’s experts Committees, given that a precise description and justified arguments have been provided.
The specific issues of the defence sector, which extend beyond the scope of the Applicant, must be developed; all impacted stakeholders have to be included in the process: customers, governments, armed forces, etc.
In conclusion, it is worth noting that these specificities have be taken into account at the very start of the project, in order to ensure the compliance of the authorisation application with REACH’s requirements, in terms of content (data collection, review period justification) and in terms of form (data confidentiality).
EcoMundo's Services
EcoMundo can accompany you throughout the entire REACH Authorisation process and provide you the following services :
- Surveilance and prioritization process analysis
- Intervention to the competent authorities
- Regulatory strategy
- Authorization dossier
Don't hesitate to contact us at contact@ecomundo.eu!
