How to anticipate the regulatory risks of chemical substances?

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What is regulatory anticipation?

Chemical substances are at the heart of the industry. Depending on their danger level for human health and the environment, their use can be restricted or even forbidden in accordance with regulatory developments.

In order to anticipate these issues and secure the industrial activity over time, steps should be taken to conduct prospective studies that help characterise the regulatory risk associated to the substances you use. This work provides you with visibility on the level of regulatory risk of each substance, and makes it possible to choose, at a very early stage of regulatory changes, which substances are to be preferred or substituted.

Beyond the regulatory compliance, this analysis consists in a game-changing decision making to design your industrial and innovation strategy. It is mainly aimed at R&D departments.

Anticipating regulatory risks unfolds in 3 essential steps:

• Identification of substances contained in your materials and processes
• Definition of the hazards associated with these substances
• Anticipation of regulatory risks & Strategic recommendations

Identification of the substances contained in your materials and processes

To successfully carry out the regulatory anticipation study, it is necessary to take into account all the chemical substances (or molecules) you use in your activity, and all those you plan to use in the more or less long term.

Thus, the study can start from:

• A portfolio of already identified substances
• Your materials

In the second case, it is necessary to break down your materials to the substance level, whether they are already used in your production line, or whether they represent a potential alternative of material considered in R&D.

The substances used in your processes (maintenance, stripping, etc.) can also be taken into account in the study.

Definition of the hazards associated with your substances

Once the substances are identified, it is necessary to determine their dangerousness level for human health and the environment so as to deduce the risk-level of their use being restricted or banned by future regulatory changes.

In that respect, this step represents a toxicological and eco-toxicological study of each of the substances identified in order to determine which ones present significant risks.

Please note that this toxicological study focuses on long-term toxicological hazards, such as:

• Carcinogenicity, mutagenicity, reprotoxicity
• Persistence, bio-accumulability
• Endocrine disruption
• Criteria of equivalent level of concern

These dangers are the ones on which the European institutions rely on to prioritise the substances that will potentially be restricted or banned in the future by regulation.

Regulatory anticipation & Strategic recommendations

Based on the substances identified during the toxicological study as likely to present a significant toxicological or eco-toxicological risk, the regulatory analysis aims at evaluating:

• The risk of each substance being included on a restrictive regulatory list
• The potential inclusion horizon

This analysis enables you to anticipate, as precisely as possible, the regulatory stakes you will face in the more or less long term, in order to prepare an appropriate action plan.

This regulatory review includes the following steps:

• Determine the current regulatory status of your substances. It is a question of checking whether these are already included in a regulatory list such as the Candidate List, Corap List, PACT, SIN List, Annex XIV, Annex XVII, Register of Intentions, etc.
• Assess the regulatory risk evolution for these substances with regards to a potential restriction/prohibition, to enable you to find technical or administrative solutions.
• Monitor your substance portfolio for these processes, starting from the PACT (Public Activites Coordination Tool stage
• Estimate the potential inclusion horizon for these substances in one of the restrictive regulatory lists
• Provide strategic and practical recommendations to secure your activity over time

This regulatory study is based on the knowledge of European institutional mechanisms to prioritise substances, the main stages of which are detailed below.

Institutional mechanisms to prioritise chemical substances

Before the inclusion of an SVHC in Annex XIV, there are several stages during which chemicals are examined at the European level by different expert committees.

It is the recommendations of these experts that make it possible to move substances along the path of restriction or prohibition. Some steps in this process include public consultations through which you can make your voice heard.

The main steps are described in the diagram below.

Defending your economic interests at the European scale

Thanks to their experience in dealing with institutions and the knowledge of their operating mechanisms, our experts can help you:

• Participate in the consulting phases in order to defend your economic interests very early on in the procedure
• Anticipate the collection of the data that will be necessary
• Develop arguments on the hazards, the scoring (ECHA's prioritisation score for the substance), your own uses or even economic impacts

Regulatory monitoring: we can guide you!

EcoMundo can assist you in your regulatory follow-up.

We offer a range of services for the regulatory watch of your substances and/or products, as well as a dedicated software tool,
‍MAT Factory
with which you can:

• Know the current changes in the regulatory status amendments of the followed substances
• Benefit from an insight on the regulatory fate of these substances and the associated deadlines
• Anticipate changes in the regulatory status of the substances monitored to develop upstream an internal strategic reflection on the solutions to be implemented