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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 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:

Thus, the study can start :

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:

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:

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:

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:

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: