The European Union’s REACH Regulation (EC) No. 1907/2006 is a cornerstone of the EU’s efforts to ensure the safe use of chemicals. Enacted in 2007, REACH aims to protect human health and the environment from the risk of chemical exposure. Among its key features, the restrictions adopted in  Annex XVII of REACH are critical for managing the risks that chemical substances may pose to health and the environment. 

The REACH Restriction Process 

The REACH restriction process is a mechanism designed to limit or ban the manufacture, placing on the market, or use of certain substances within the European Union when it is determined that they pose unacceptable risks to health or the environment. This process can be initiated by any EU Member State or by the European Chemicals Agency (ECHA) itself if there are grounds for concern. There are 3 phases in the restriction process: 

Phase 1: Preparation and submission of a restriction proposal 

Phase 2A: Consultation 

Phase 2B: Opinion development 

Phase 3: Decision and follow-up 

Phase 1: Preparation and Submission of a Restriction Proposal 

In this phase, if they have concerns that a substance poses a risk to human health or the environment ECHA, the EU member states, or the European Commission (EC) may exert their right to initiate a restriction process. Once the decision has been made to begin the restriction process, the applicable party must issue a notice of intention to submit the restriction dossier 12 months prior to submission. ECHA will list the substance in the registry of intention (ROI) to indicate its pending status. 

The restriction dossier shall include information on hazard and risks, available alternatives, and a justification for an EU-wide restriction. It shall also demonstrate appropriate risk management measures and analyze the socio-economic impacts of such a restriction. ECHA may launch a call for evidence to support the notifier. Within 30 days of receiving the dossier, ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC) determine whether the submitted restriction dossier conforms with REACH requirements. If it does, a consultation is launched on the conforming restriction report. 

Phase 2A: Consultation 

Conforming restriction reports (The Annex XV report) will be published on ECHA’s website without any confidential information, and they will be open for comments from interested parties for 6 months. Once SEAC and RAC’s draft opinions are ready, they will be posted on ECHA’s website and interested parties will have 60 days to comment.  

Phase 2B: Opinion Development 

RAC and SEAC develop opinions with the support from the Forum for Exchange of Information on Enforcement (Forum) and ECHA. In 9 months of the publication of the conforming restriction report, RAC needs to draft an opinion if the suggested restriction is appropriate for reducing the risk to human health and the environment. This opinion is based on the dossier, the Forum and consultation comments. Within 9 months of the publication of the conforming restriction report, SEAC needs to draft an opinion on the socio-economic impacts, the Forum’s advice, and the consultation comments. Within 12 months, SEAC will need to draft its final opinion.  

Once RAC and SEAC’s opinions are adopted, they will be compiled by ECHA and sent to the EC. 

Phase 3: Decision and Follow-up 

Within 3 months of receiving compiled opinion, the EC will submit it to the World Trade Organization (WTO) to ensure that it doesn’t create any technical barriers to international trade. If WTO has no comments, the proposal will enter into a trilogue between the EC, the Council and the EU parliament. The restriction will be adopted when they reach a decision unanimously.  

Timeline of restriction process: 

It can sometimes be difficult to predict the restriction process timeline as there are many uncertainties that can affect the timeline. The current PFAS restriction proposal is an excellent example of this.  

 

 

 Note that the intent to submit a restriction dossier for PFAS was notified in 2021 but the 5 member states submitted the restriction dossier in 2023. According to the standard timeline above, RAC and SEAC should have drafted their final opinions by March of 2023, which is 12 months after the Annex XV report is provided, but they are still evaluating the large number of comments received from the impacted sectors.  

After the adoption of a decision, there may be an 18-month transition period after the restriction enters into force with use-specific and time-limited exemptions and a 5–12-year derogation period depending on the application.  

Summary 

The Registry of Intention for restricted substances is the go-to place for the public to learn about the restriction process of a substance. Once a restriction is decided and moved into the restricted substance lists, it may take it a period of time to enforce, depending on the final decision.  

How H2 Can help 

There are many substances of concern used globally, and it is difficult to understand what they are and how they may impact the supply chain. This makes regulatory compliance or anticipating the other business drivers like early obsolescence risk an overwhelming challenge.  

H2 offers manufacturers deep visibility into their product portfolio, making it easier to identify their risks and demonstrate due diligence. We can provide defensible due diligence regarding restricted substances like PFAS in the supply chain to chemical industrial stakeholders. 

Reach out to H2 Compliance if you need any support on restriction substances in articles and products. 

Published: April 12, 2024