REACH Annex XIV : Understanding the EU REACH Authorisation List

In the complex world of European Union (EU) chemical regulations, The Authorisation List, formally known as Annex XIV, stands as a crucial document outlining substances that demand special approval before usage within the EU. These substances, deemed particularly hazardous, are subjected to a stringent authorization process, and approval is granted only when no viable alternatives are available. In this blog post, we will explore the intricacies of The Authorisation List, shedding light on its significance, the authorization process, and the dynamic nature of this regulatory framework.

What is REACH Annex XIV Authorisation List ?

REACH Annex XIV is also called the REACH authorisation list. It contains a list of substances subject to authorization under EU REACH regulation. Substances on this list are selected from the REACH SVHC list and they cannot be placed on the market or used after a given date ("sunset date"), unless authorization is granted for their specific use, or the use is exempted from authorization.

Significance of REACH Annex XIV:

The inclusion of a substance in Annex XIV signifies that it is considered of very high concern due to its inherent properties, such as being carcinogenic, mutagenic, toxic to reproduction, persistent, bioaccumulative, and toxic (PBT), or very persistent and very bioaccumulative (vPvB). These substances pose significant risks to human health and the environment, and their use is tightly regulated to minimize adverse effects.

Why is Authorization Necessary in Annex XIV?

Authorization is required for substances listed in Annex XIV because they are considered particularly risky. These substances may have harmful effects on human health or the environment, and their use is allowed only under specific conditions. The authorization ensures that these substances are used safely and that viable alternatives are sought whenever possible. By subjecting certain substances to the authorization process, the EU aims to:

• Protect Human Health: Restricting the use of hazardous substances safeguards the health of workers, consumers, and the general population who may come into contact with these chemicals.

• Preserve the Environment: Authorisation prevents the release of harmful substances into the environment, minimizing the ecological impact and contributing to the conservation of biodiversity.

• Stimulate Innovation: The authorization process encourages industries to explore and adopt safer alternatives, driving innovation in the development of more sustainable products and processes.

Key Components of the Annex XIV the REACH Authorisation List

• Special Authorization Requirement: Substances included in Annex XIV require explicit authorization from the European Chemicals Agency (ECHA) before they can be used for specific purposes. This stringent requirement ensures that only essential uses are permitted, and alternatives are sought whenever possible.
• Approved Uses and Conditions: The Authorisation List provides detailed information about the approved uses of each substance. This includes the specific applications or industries where the substance can be used, and the conditions under which its use is permitted. This precision helps prevent the unnecessary exposure of individuals and the environment to hazardous substances.
• Sunset Date: Each substance on the Authorisation List is assigned a "sunset date," which signifies the deadline after which the substance cannot be placed on the EU market unless an exemption or authorization has been granted. The sunset date is a crucial aspect of the regulatory framework, driving a sense of urgency in finding safer alternatives and phasing out the use of hazardous substances.
• Dynamic Nature: The Authorisation List is not static; it is subject to periodic updates. New substances may be added based on emerging scientific evidence, and the sunset dates for existing substances may be adjusted. This dynamic nature ensures that the regulatory framework remains adaptive and responsive to evolving knowledge about the risks associated with different substances.

Authorisation List (List of substances included in Annex XIV of REACH)

List of Substances of Very High Concern (SVHC) Subject to Authorisation under the EU REACH regulation. The Candidate List contains SVHC identified by the European Commission in agreement with the Member States and assisted by the European Chemicals Agency (ECHA). Substances included in the Candidate List are afterward prioritized for inclusion in Annex XIV List of Substances Subject to Authorisation (Authorisation List).

REACH establishes an Authorisation process by which a manufacturer, importer, or downstream user shall not place a substance of very high concern (SVHC) on the European market for use or use it himself without obtaining an authorisation. REACH criteria for SVHC identification as defined in Article 57 are:

(a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B by section 3.6 of Annex I to Regulation (EC) No 1272/2008.

(b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B by section 3.5 of Annex I to Regulation (EC) No 1272/2008.

(c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development by section 3.7 of Annex I to Regulation(EC) No 1272/2008.

(d) substances that are persistent, bioaccumulative, and toxic by the criteria set out in Annex XIII of this Regulation.

(e) substances that are very persistent and very bioaccumulative by the criteria set out in Annex XIII of this Regulation.

(f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfill the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.

Applying for Authorization

In the intricate landscape of chemical regulation governed by the REACH framework, obtaining authorization for the use of specific substances is a critical process. Manufacturers, importers, downstream users, or their appointed consultants, often referred to as Only Representatives, are eligible to spearhead this application journey. One key emphasis from the European Chemicals Agency (ECHA) is the proactive approach of applicants. The ECHA encourages entities to initiate the authorization process well before the latest application date listed on their website. This strategic timing is vital to ensure the seamless continuation of substance use during the application assessment period. For applicants, the authorization process involves a delicate balance between the necessity of continued substance use for industrial processes and the imperative to demonstrate responsible and safe practices. Navigating this pathway requires a nuanced understanding of the regulatory landscape, effective communication with relevant stakeholders, and a commitment to meeting the stringent criteria set forth by the REACH regulation.

In essence, the authorization application process encapsulates the commitment of both regulatory bodies and industry players to foster a chemical environment that prioritizes safety, innovation, and sustainability. It is a collaborative effort aimed at ensuring the responsible use of substances while safeguarding the well-being of individuals and the environment.

Latest update to REACH authorization List:

According to REACH Regulation Article 56, the substances which are listed in Annex XIV cannot be used or placed on the market after the “sunset date”, unless the authorisation is granted. The European Chemicals Agency (ECHA) recommends the priority substances to be included in Annex XIV about every two years. These priority substances are chosen from the Candidate List.

Click here for the latest EU REACH Authorisation list

In conclusion, Annex XIV is a critical instrument in the EU's efforts to regulate hazardous substances effectively. It reflects the commitment to protecting human health and the environment while promoting the responsible use of chemicals. The authorization process, with its emphasis on alternative assessment and public involvement, ensures a comprehensive and transparent approach to managing the risks associated with these substances. The dynamic nature of the regulatory framework demonstrates the EU's dedication to staying abreast of scientific advancements and continuously enhancing its chemical safety measures.