How to prove to the Authorities that my activity complies with REACH Authorisation?

In order to be as comprehensive and operational as possible, this article focused on REACH Authorisation compliance, is subdivided into two parts:

• Part 1: practical checklist of the key elements to be included in a compliance report
• Part 2: detailed presentation of the context, content of an Authorisation dossier and key elements of a compliance initiative in case of inspection

Compliance checklist

The main elements of a REACH Authorisation compliance initiative are synthesised in what follows:

• 1 - Check 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 - Check that 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.

The following table details the main elements to be considered in the compliance analysis. This inventory is not exhaustive, to the extent that the content of an inspection depends on the specific case of each company, as well as on the priorities of the Authorities.

General description of the activity Justification of compliance with the use of the substance (functional properties and levels of performance, type of process) Annual quantities used Correspondence table of each potentially exposing step with each associated contributing scenario Detail of the workers concerned (number, activities, populations/functions) Operational conditions Presentation of the activities of each process Frequency and duration of each operation Risk management measures Risk management procedures in place: training of employees, supervision of activities, progress plan, ... Description of ventilation and filtration systems: type of equipment, air change rate, efficiency, maintenance Description of the personal protection equipments in use (masks, gloves, …): reference/norm of equipments, protection factors, ... Measurements/monitoring History of the concentration measurements in the ambient air History of the emission measurements in air, water, soils History of the biomonitoring measurements (blood, urine)

• 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 REACH IT.
• 4 - Prepare a compliance report
• The compliance report aims at demonstrating your compliance to the Authorities in case on inspection. 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.

It is important to note that the information brought by the compliance analysis will have to be regarded from the perspective of the global chemical risk; REACH is therefore not to be considered as an isolated regulation but as being in interaction with other regulatory frameworks.

REACH Authorisation compliance: general presentation

Reminder of the acquisition conditions of a REACH Authorisation

The REACH procedure aims at obtaining a temporary derogation allowing the use of a substance beyond its phase-out date in the European Union. Said Authorisation is granted by the European Commission, on the basis of an assessment and a recommendation made by the European Chemicals Agency (ECHA).

An application for Authorisation can be submitted:

• As a downstream application by the downstream user of the substance
• As an upstream application by an upstream actor of the supply chain of the substance (e.g. manufacturer).

In the context of the upstream application, a company that is situated downstream in the applicant’ supply chain may be covered by this Authorisation if the following threefold condition is met:

• Downstream position in the supply chain: the applicant provides the concerned substance to the covered company (Art. 56[1(e)])
• Compliance with the conditions of the Authorisation: operational conditions and risk management measures implemented comply with those of the application for Authorisation (Art. 56[2])
• Notification: the company covered by an upstream Authorisation notifies ECHA of its use of the substance within three months of the first supply of the substance (Art. 66[1]).

The enforcement of the REACH regulation is of the responsibility of Member States’ supervisory authorities. A user covered by an Authorisation therefore has to be able to demonstrate his compliance with the requirements of the Authorisation dossier. ECHA implements and regularly updates a registry of downstream users of substances subject to Authorisation, to which access is granted to the Member States’ competent authorities (Art. 66[2]).

All companies covered by an Authorisation are potentially concerned by REACH Authorisation inspections. In the case of companies covered by an upstream application, Authorisation compliance can be relatively complex to demonstrate as it is possible that the dossier does not specifically describe the industrial situation of the company covered.

In what follows, we propose a presentation of an application for Authorisation dossier as well as a description of the key compliance elements in case of inspection.

The content of an Authorisation dossier

The Authorisation dossier contains all the elements that justify the need for an Authorisation and therefore constitutes the basis for compliance inspection for the authorities. It consists of three parts:

• The Chemical Safety Report (CSR) includes a description of the process implemented (that takes into account risk management measures and operational conditions), an assessment of exposures (of workers, consumers or the general population) as well as associated risks.
• The Analysis of Alternatives (AoA) aims at demonstrating the infeasibility of a substitution of the substance and at describing the implementation of alternative solutions.
• The Socio-Economic Analysis (SEA) synthesises the results of the cost-benefits analysis, based on the risk assessment as well as the economic and strategic situation of the Applicant.

The Chemical Safety Report (CSR) gathers all the elements relevant to the handling of the substance on-site as well as the risks for human health and the environment. It therefore constitutes a key element for the control authorities. According the ECHA’s template, the CSR has the following structure:

Part A:

1. Summary of risk management measures
2. Declaration that the risk management measures are implemented
3. Declaration that the risk management measures are communicated

Part B:

1. Identity of the substance and physical and chemical properties
2. Manufacture & uses
3. Classification & labelling
4. Environmental fate properties
5. Human health hazard assessment
6. Human health hazard assessment of physicochemical properties
7. Environmental hazard assessment
8. PBT and vPvB assessment
9. Exposure assessment
10. Risk characterisation related to combined exposure

In order to carry out the exposure assessment, the section 9 (part B) of the CSR details operational conditions (OC) and risk management measures (RMM) related to each process step of the use of the substance. Risk characterisation, a key element of the granting of an Authorisation, is carried out on this basis and detailed in section 10. It is extremely important for a company that is covered by an Authorisation to be able to demonstrate its compliance with both OC and RMM that are described in the dossier.

Exposure assessment takes into account each operation of an industrial process that may potentially lead to an exposure. To that effect, the process is subdivided into several workers contributing scenarios (WCS) or environmental contributing scenarios (ECS). For each contributing scenario, exposure related to the use of the substance is estimated either based on actual measurement data (ambient air concentration, effluents measurements, …) or on the basis of the results of modelling studies, carried out with dedicated software.

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The risk associated with those exposures is calculated in section 10 of the CSR. To that effect, the frequency and duration of each operation, as well as the differences between different operators, have to be taken into account to characterise the long-term level of risk.

Since 2015, and so as to offer a synthetic view of the structuring elements of an application for Authorisation, a summary of the main parameters has to be included to the CSR. This summary table synthesises, for each contributing scenario:

• Descriptor codes (ERC/spERC ou PROC)
• Annual quantity used
• Technical risk management measures (ventilation, containment…)
• Organisational risk management measures (duration, frequency, supervision…)
• Personal protective equipment
• Treatment efficiency of aqueous and atmospheric releases
• Emissions to water, air and soil

A comprehensive description of the elements to be included in this summary table is provided in the following annotated format from ECHA.

In addition to this information, an Authorisation may entail additional specific conditions as recommended by ECHA’s expert committees, such as complementary risk management measures (e.g. monitoring, biomonitoring or emissions measurement campaigns) or reporting on the substitution initiative (progress report of the alternative research/implementation works).

Demonstrate your compliance to the requirements of an Authorisation dossier

Coordinated at a European level, chemicals enforcement controls are carried out in France by the DREAL (Directions Régionales de l’Environnement, de l’Aménagement et du Logement) inspectors, labour inspectors, DGCCRF (Direction de la Concurrence, de la Consommation et de la Répression des Fraudes) agents or customs agents. Each control body acts according to its field of expertise (for example, the DGCCRF focuses on the verification of the labelling of substances, whereas the labour inspection focuses on the implementation of risk management measures for workers).

In France, failure to comply with the REACH regulation may be fined up to €75,000 and may face a two-year prison sentence for physical persons and a fine of €375,000 for companies, as well as complementary measures such as temporary or permanent closures or removal of the right to practice.

In 2013, close to 7,500 inspections related to the use of chemical substances have been carried out, off which 4,500 concerning the REACH and/or CLP regulation.

Until recently, REACH inspections were focused on Safety Data Sheets, labelling or registration duties. Specific controls are, however, planned for companies that are covered by an Authorisation. Such controls aim at verifying that actual use conditions of the substance comply with the content of the Authorisation dossier, with two main elements:

• Operational conditions refer to all the parameters that have a quantitative impact on the exposure of humans or the environment, for example: substance specifications, duration and frequency of exposure, quantity of substance used, exposure environment (size of the room), ...
• Risk management measures include all the elements of the company’s policy to address risks for human health and/or the environment, including: ventilation and filtration systems, aqueous/atmospheric emissions treatment systems, personal protection equipments (masks, gloves, …)

In the context of Authorisation-focused inspections, a company that uses a substance subject to Authorisation must be able to demonstrate its compliance with these two elements for each contributing scenario of the Authorisation dossier. To do so, said inspections 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.