Post-authorization compliance
How to prove that my activity is compliant with REACH Authorisation?
To use a chemical substance after its sunset date in the European Union, you have to make a REACH Authorisation application. It must meet several compliance requirements in the acquisition conditions and the constitution of the dossier to be valid to the Competent Authorities. What are the compliance steps for your Authorisation dossier so you can anticipate any control from the Competent Authorities?
Most important elements to include in your compliance report
To ensure your compliance with REACH Authorisation, you must follow 4 important steps:
1. Verify that the substance is covered by an Authorisation
A use that is covered by an Authorisation has an Authorisation number (formatted as REACH/x/x/x) that is to be indicated in section 15 of the Safety Data Sheet (SDS) of the substance or the mixture concerned. It is therefore essential to possess an up-to-date SDS that includes this Authorisation number.
It may also be of interest to contact the supplier of the substance, in order to obtain its confirmation of coverage by the Authorisation, as well as to obtain potential recommendations regarding requirements in terms of operational conditions and risk management measures associated to the Authorisation.
2. Your use complies with that of the Authorisation
Each Authorisation is granted for a specific use, which is defined by the sought-after functional properties and levels of performance of the substance as well as by the conditions of implementation of the substance. It is essential to check that your use corresponds to that of the Authorisation dossier.
There are a certain amount of elements to take into consideration for the compliance evaluation:
- General description of the activity
- Operational conditions
- Risk management measures
- Concentration, emission and biomonitoring measurements
3. Notification
The use of a substance that is subject to Authorisation and covered by an upstream application has to be notified to ECHA within three months of the first supply of the substance (Art. 66[1]). The notification is carried out via the REACH IT platform.
4. Prepare a compliance report
In case of inspection, the compliance report aims at demonstrating your compliance to the Authorities. To this end, it constitutes a summary of the data collected during the steps 2 and 3. It notably has to ensure the continuity and permanence of your compliance over time, notably in the event of a change in personnel.
Demonstrate your compliance to the requirements of an Authorisation dossier
Controls on chemical products are coordinated at the European scale and carried out, in France, by:
- the DREAL inspectors
- labour inspectors
- DGCCRF agents
- customs agents
Each control body acts according to its field of expertise. For instance, the DGCCRF focuses on the verification of the labelling of substances and the labour inspection focuses on the implementation of risk management measures for workers.
In France, failure to comply with REACH regulation measures can lead to sanctions.
- A natural person risks to be fined up to €75,000 and may face a two-year prison sentence
- Legal entities expose themselves to a €375,000 fine as well as complementary measures such as temporary or permanent closures or even removal of the right to practise
Until recently, REACH inspections were focused on SDSs, labelling or Registration duties. However, specific controls are planned for companies that are covered by an Authorisation.
In the context of Authorisation-focused inspections, a company that uses a substance subject to Authorisation must be able to demonstrate its compliance to operational conditions and risk management measures. This means that said inspections will have to be anticipated in order to finely identify and formalise these elements.
In addition to the descriptive elements, it will also be of interest to gather all the monitoring data for the site concerned: ambient air concentration, biomonitoring (in blood or urine) and emissions in air, water or soil.
It is essential to anticipate an Authorisation inspection, for all companies covered by an Authorisation, and more specifically for companies covered by an upstream application.
A compliance report will have to be prepared, with a twofold objective:
1 - To collect and centralise the data: relate actual operational conditions and risk management measures to those described in the Authorisation dossier
2 - To discuss the compliance and potential improvement options towards compliance.
In addition to these descriptive elements of the process implemented, it will be interesting to prepare all the site monitoring data: concentration measurements in ambient air, biomonitoring (amount in the blood or urine) and emission measurements in the air, water or soil.
