The REACH Authorisation process
The Authorisation procedure is an option for risk management established in REACH Regulation, at the European scale.
It applies to substances identified as “very concerning” and identified as presenting an elevated risk for human health or the environment. These substances can be of 4 types:
- CMRs 1A and 1B : carcinogenic, mutagenic & reprotoxic substances
- PBTs : persistent, bioccumulative & toxic substances
- vBvPs : very persistent and very bioccumulative substances
- Substances of equivalent concern: endocrine disruptors or respiratory sensitizers, for instance
Substances included in REACH’s Annex XIV are all submitted to Authorisation. Their use is therefore bound to be prohibited on the European territory, in the short-term (36 to 48 months after their inclusion to the list). “REACH Authorisation” implies a temporary derogation to the restriction of use for a given substance or use. Three exemption review periods are generally considered: 4, 7 or 12 years.
The “Latest Application Date” is also very important in the Authorisation process. It is the recommended deadline for the submission of an Authorisation request, it guarantees the use of the substance until the decision of the European Commission. It is generally scheduled 18 to 21 months after the date of inclusion into Annex XIV.
What’s in an Authorisation request dossier?
The creation of an Authorisation dossier requires between 12 and 18 months of preparation and gathers 3 key documents:
- The Chemical Safety Report
- The Analysis of Alternatives
- The Socio-Economic Analysis
The Chemical Safety Report
The Chemical Safety Report (or CSR) aims at characterising the risks generated by the use of a given substance.
This evaluation implies the identification of human and environmental expositions to the substance (usually with a detailed presentation of the substance’s cycle of life).
The objective: provide ECHA experts with a good comprehension of each and every one of the phases of exposition to the substance as well as with the associated risk management measures.
The evaluation of those risk levels is based on: the potential realised measures (air concentration, airborne emissions…) and a modelling of the expositions according to specific tools and models.
The Analysis of Alternatives
It is also known as the AoA. Its goal is to:
- Present the efforts for the purpose of the substitution of the substance affected by the Authorisation request
- Detail the feasibility of the alternatives envisioned
- Determine the substitution strategy of the company
One of the fundamental elements of this analysis is the definition of the function of the substance. This part gathers, among other things, a presentation of the functional properties and the expected levels of performance of the substance.
The description of the potential alternatives takes into account:
- Economic feasibility
- Technical feasibility
- Availability and risks for human health and the environment
Thus, the objective is to justify the length of the review period sought, using the description of the company’s substitution strategy.
This analysis aims at realising a comparative, money-based evaluation of the impacts related to the continuation of use of said substance.
In order to establish this comparison, 2 scenarios are defined:
- Use scenario
This scenario determines the potential repercussions of granting an Authorisation – and thus of the continuation of use of the substance for the duration requested – on human health and the environment.
- Non-use scenario
It tackles the issues that a refusal of Authorisation would have, whether they be economic, social, etc.
When it is possible, the effects related to these two scenarios are subjected to a quantitative, money-based evaluation according to specific methodologies.