Removing authorisation from REACH may jeopardise key principles for effective chemicals regulation

To fulfil the aims set out in the Chemicals Strategy, REACH will be revised. One of the processes under scrutiny is the REACH authorisation process.

While ChemSec has criticised the shortcomings of the current system and its implementation, we consider the authorisation process to be one of the most important parts of REACH, because it embodies key principles for effective chemicals regulation. Without authorisation, REACH loses not just its “A”, but also its teeth.

In this publication, we explain what is at stake and which key parts of REACH we must save for the future system – whether they are named “authorisation process” or something else.

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The Chemicals Strategy provides room for improvement

The Chemicals Strategy for Sustainability, launched by the Commission in October 2020, aims to increase the protection of EU citizen health and our environment – as well as transforming the industry towards safe and sustainable chemicals. The goal is a toxic-free environment.

Acknowledged by the strategy, current EU chemicals regulation and its implementation has a number of significant weaknesses. These make the level of protection insufficient while also being complex for industry to comply with.

By revising REACH, the Commission aims to make the legislative processes more efficient, the protection of human health and the environment higher, the burden for all stakeholders lighter, and the decision-making faster, more consistent and predictable.

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Unsatisfactory implementation of the authorisation process

One idea presented by the Commission is to revise the processes for authorisation and restriction under the REACH review.

The Commission is now looking into four different scenarios:

  1. Keep the authorisation process as it is
  2. Improve the authorisation process
  3. Merge the authorisation and restriction processes
  4. Remove the authorisation title from REACH

We agree with the Commission that the authorisation process hasn’t worked efficiently and this is the right time to address these problems. However, the radical idea to entirely remove the authorisation title from REACH makes us deeply worried. We are concerned that removing the authorisation process may work against the targets of the Chemicals Strategy.

Therefore, we urge the Commission to ensure that any revised or new process does not lose the key principles currently held by the authorisation process.

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The principles at stake

To make sure that the new regulation becomes more efficient, important core principles must guide this revision. These principles are not new, but were in fact part of shaping the current REACH system.

It is time to revisit them. We would like to remind the Commission about these principles and give our rationale to why they must be “keepers” in the REACH revision.

The principles are:

  • The Polluter Pays Principle
  • The Precautionary Principle
  • The Substitution Principle
  • The Right to Know
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The Polluter Pays Principle places burden of proof on industry

Historically, it has been proven that efficient and protective chemicals regulation require that the burden of proof is placed on the companies producing and using hazardous chemicals. This means that companies must prove that the chemicals they want to use are safe, instead of governments having to prove harm. Additionally, producers of chemicals are liable for the damages they cause. This is fundamental, as it creates incentives to substitute hazardous substances.

Today, the authorisation process works under this principle. It is up to individual companies to justify continued and time-limited use of a Substance of Very High Concern (SVHC) in their applications for authorisation.

The restriction process, on the other hand, requires Member States or ECHA (commissioned by the Commission) to produce restriction dossiers and prove risk. This requires significant resources and work from individual member states and ECHA, at the expense of taxpayers.

 

√  Keep: Burden of proof on companies to provide data on their chemicals, and to justify use of hazardous chemicals

Expand: Enforcement and consequences for companies not providing required information

Χ  Discard: The possibility for companies to stall regulatory action by not providing data

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The Precautionary Principle and the Hazard Based Approach can override Paralysis by Analysis

The Precautionary Principle makes it possible to act without all data at hand. In fact, everyone working in this field knows that data is rarely conclusive. Still, as of now, the burden of proof before addressing a substance, either through authorisation or restriction, has been extremely high. In fact, it has been concluded that the precautionary principle has “never been used”.

Linked to the precautionary principle is the hazard-based approach, also called generic risk assessment. This approach states that certain hazardous properties are cause for such high concern that it is not necessary to assess the exposure to understand that the risk of using such a chemical is unacceptable.

The authorisation process starts with identifying a substance as being of very high concern (SVHC), based on its intrinsic hazardous properties only. Restrictions, on the other hand, are initiated only when authorities can prove a risk, which requires information on both hazardous properties and exposure.

Hazard-based regulation is more efficient, as stated in the Chemicals Strategy: “…hazard approach is simpler, faster and provides clear signals to all actors”. By eliminating hazardous substances, you immediately eliminate the risk of harm. Therefore, a system based on hazard is crucial for efficient regulation.

One action under the Chemicals Strategy is to amend REACH §68.2, in order to extend the hazard-based approach and restrict SVHCs in consumer and professional uses.

While we welcome this proposal, our concern is that up until now, the Commission has been neither fast nor effective. Take – for example – the inclusion of substances on the Authorisation List, where the Commission has dragged its feet for no apparent reason. Therefore, there is a need to include process time limits in the amended version of §68.2 to make it efficient.

An important new concept proposed under the Chemicals Strategy is the concept of essential use. This concept only allows continued use of the most harmful chemicals if the end use is essential for health or safety, or critical for the functioning of society. We warmly welcome this concept, which supports the precautionary principle and – if implemented effectively – can help avoid paralysis by analysis to a larger extent.

 

√  Keep: Identification and communication of intrinsic properties

Expand: The hazard-based approach, possibilities to use the Precautionary principle and introduce process time limits

Χ  Discard: The lack of full scientific certainty as a reason for postponing regulatory action

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The Substitution Principle triggers innovation

The general intention of the Substitution Principle is that a chemical substance must be substituted when a safer alternative is available. But substitution can be costly and complex; without incentives for companies to shift to safer alternatives, it rarely happens. Strict regulation has proven to be a very effective incentive.

Predictability and clarity is key to transform industry in line with the Substitution Principle. When regulation, implementation and the political messages are aligned in terms of direction and sanctions, industry can adapt and adjust. If the limits are unclear, the political message vague and the implementation lax, the message towards industry is clouded and the transformation will not happen.

Identification of SVHCs for the Candidate List, as well as for ChemSec’s own SIN List, have proven to give companies predictability, while also triggering innovation and substitution.

Assessments of available alternatives, as done in the evaluation of application for authorisation, have proven to be very difficult. There have been word-against-word discussions, often not leading anywhere. A more effective way to assess alternatives must therefore be put in place to encourage substitution more efficiently.

 

√  Keep: The Candidate List for identification of Substances of Very High Concern

Expand: Incentives for substitution

Χ  Discard: The focus on the companies wanting to continue to use SVHCs ; focus on the ones using and producing alternatives instead

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The Right to Know lets stakeholders make informed decisions

According to REACH, Article 33 gives consumers – and others – the right to know if a product contains a Candidate List substance.

Aside from being in line with common sense and democratic principles, the Right to Know Principle is important also for the development of chemical policies. Experience shows that citizens care about their health and the environment, and if they have access to information, they choose safer products. This behaviour can be a very strong incentive for companies to shift to safer chemicals.

But consumers are not the only ones who benefit from this information. It is also crucial along all supply chains, as well as for waste managers, to have access to this information, so that they can treat products containing SVHC correctly.

If the Candidate list is removed, it would mean that the link to the Waste Framework Directive and the SCIP database is lost. This disconnection would significantly jeopardize the future of toxic-free material cycles, a fundamental part of circularity.

 

√  Keep: Article 33 and its link to the Candidate List of Substances of Very High Concern

Expand: The information about chemicals in consumer products

Χ  Discard: The possibility for industry to claim confidentiality to hinder transparency

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A new system must be based on these principles

We urge the Commission to ensure that a future system, with or without an authorisation process as of today, builds on the principles listed above. If these principles are lost, the Commission will fail to deliver on the objectives of the Chemicals Strategy, as they are key to all efficient chemicals regulation.

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