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Introduction to the Authorisation List

Authorisation list

The Authorisation List is a list of substances considered as dangerous according to the European Union chemical regulatory framework, REACH. This list includes substances that are deemed to be of very high concern due to their potential adverse impact on human health and the environment. Hence, the use of these substances is subject to strict authorisation procedures. The aim of this article is to shed light on the importance of including substances on the Authorisation List and how it affects both industries and consumers.

Under the EU law (REACH), substances on the Authorisation List should only be used after obtaining authorisation from the European Chemicals Agency (ECHA). To obtain such authorisation, companies must prove that the risks associated with the use of these substances are adequately controlled or, in some cases, that the socio-economic benefits of using them outweigh the risks. This aims to ensure that the use of these substances is safe for human health and the environment, and to push industries to find safer alternatives to these hazardous substances.

The Authorisation List is divided into two categories: Candidate List and Authorisation List. The Candidate List is a list of substances that are intended to be included in the Authorisation List. These substances have been identified as Substances of Very High Concern (SVHC) and are subject to strict controls. Substances are added to this list if they meet one or more of the criteria set out in Article 57 of REACH. Once a substance is included on the Candidate List, companies have to communicate this information downstream to their customers and end-users to facilitate informed substitution.

On the other hand, the Authorisation List is a list of substances that have already been included and are subject to authorisation. It includes substances that are deemed to pose a high risk to human health and the environment. When a substance is included on this list, companies can only continue using it after obtaining an authorisation from ECHA. Companies may also submit an application to add a substance to the Authorisation List based on new scientific evidence.

The inclusion of a substance on the Authorisation List has several impacts on industries, including the need for companies to find safer alternatives, which can require significant investments in research and development. For example, the substitution of the phthalates, a group of chemicals commonly used in plastic production and included in the Authorisation List, has been a costly and challenging process for the industry. However, the replacement of these hazardous substances with safer alternatives ensures the protection of human health and the environment in the long run.

The Authorisation List also has an impact on consumers as it ensures that hazardous substances are not present in the products they use. Consumers are often unaware of the presence of such substances in the products they use, and inclusion on the Authorisation List affects their purchasing decisions. They can now choose safer products and avoid those containing substances on the list.

In conclusion, the Authorisation List plays a crucial role in ensuring the safe use of chemicals in the EU, protecting human health, and preserving the environment. The inclusion of substances in this list incentivizes industries to find safer alternatives and allows consumers to make informed decisions about the products they use. Companies must comply with authorisation requirements, and consumers must be aware of these substances’ potential risks. Hence, a collaborative approach between the industry and the public is required to ensure the safe use of these hazardous substances.

Criteria for Inclusion in the Authorisation List

Criteria for Inclusion in Authorisation List

The European Chemicals Agency (ECHA) created the Authorisation List under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation. The list aims to control the use and sale of Substances of Very High Concern (SVHC) and subsequently remove hazardous chemicals from products. Moreover, inclusion in the Authorisation List poses restrictive measures on SVHC use and sale, sending signals that producers and importers of substances should seek alternatives.

Substances must undergo necessary evaluation by ECHA to determine whether they meet the criteria for inclusion into the Authorisation List. The criteria are divided into two groups: substances identified on the Candidate List and new substances under consideration.

Substances Identified from the Candidate List

Criteria for substances identified from the Candidate list includes:

  1. PBT and vPvB Properties – a substance with Persistent, Bioaccumulative, and Toxic (PBT) and very Persistent, very Bioaccumulative (vPvB) properties. These are substances that persistently remain in the environment and accumulate in the food chain. Given their risks, the European Union aims to replace them with less hazardous chemicals where possible.
  2. Carcinogenic, Mutagenic, Reprotoxic (CMR) – a substance that is carcinogenic, mutagenic, or toxic to reproduction. These substances are of particular concern because of their negative effects on human health. The Authorisation List seeks to eliminate or reduce exposure to these substances as much as possible.
  3. Endocrine-Disruptors – these are substances that can cause hormonal fluctuations in human and animal bodies. The presence of endocrine disruptors affects the development and functioning of the nervous and immune systems, leading to long-lasting health issues. The ECHA will evaluate all substances that exhibit known endocrine-disrupting properties during their review process and could include them in the Authorisation List.
  4. Very High Concern – substances that pose a significant risk to human health or the environment and appear on the Candidate List, after a thorough evaluation, become candidates for inclusion in the Authorisation List. These substances can have PBT, vPvB, or CMR properties, or their toxicity properties cause a risk to humans or the environment.

New substances under consideration

When evaluating new substances under consideration for inclusion in the Authorisation List, the primary criteria that the ECHA considers are analogous to the inclusion of substances identified from the Candidate List. However, the evaluation process for new substances may differ from that of substances on the Candidate List.

  • Thorough evaluation – before being made available for use, new substances must go through a thorough evaluation to determine their toxicity and adverse properties that may risk human and environmental health. Manufacturers must provide sufficient data to regulators to get an initial review before the substance’s use.
  • Similarity to Listed Substances – new chemicals bearing a close resemblance to substances already listed in the Authorisation List must undergo a review process to determine whether they pose similar risks. If yes, they may be added to the inventory, thus restricting their use and sale without a valid Authorisation license.
  • No Alternatives – authorization may be granted for a listed substance where no alternative is available. However, in this case, the ECHA puts strict measures on the product’s use to restrict human and environmental exposure.

The criteria for inclusion in the Authorisation List seek to limit the number of hazardous chemicals used and sold in the European Union, to reduce human and environmental health risks. The ECHA and other regulatory bodies’ tireless efforts will assist in moving toward safer manufacturing practices and eventually lead to a safer world. Manufacturers and importers are reminded to conduct assessments of their products periodically, to ensure compliance and avoid regulatory entanglements that could impact their business’ bottom line.

Top Substances Recommended for Inclusion in the Authorisation List

authorisation list

The European Chemicals Agency (ECHA) oversees the implementation of the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation in the European Union (EU) and the European Economic Area (EEA). One of the regulatory measures of REACH is Authorization, which aims to ensure that the use of Substances of Very High Concern (SVHCs) is adequately controlled and justified based on an analysis of the risks and benefits for human health and the environment. The Authorization process allows ECHA to include these SVHCs in the Authorization List, also known as Annex XIV, which is a publicly available list of substances that cannot be used or placed on the market without prior authorization from ECHA.

The following are the top 3 substances recommended for inclusion in the Authorization List:

1. Perfluorohexane-1-sulphonic acid and its salts (PFHxS)

perfluorohexane-1-sulphonic acid

PFHxS is a per- and polyfluoroalkyl substance (PFAS) that has been used in a variety of industrial and consumer applications, such as in firefighting foams, waterproof textiles, and food packaging materials. PFHxS is persistent, bioaccumulative, and toxic to reproduction, with potential effects on the liver, thyroid, immune system, and the developing fetus. PFHxS has been detected in various environmental media, including air, soil, water, and biota, as well as in human blood and breast milk.

As a result, ECHA’s Committee for Risk Assessment (RAC) has recommended PFHxS to be identified as an SVHC due to its intrinsic properties that cause probable serious effects to human health and the environment. RAC also considers that no current regulatory measures address the risks posed by PFHxS and that there are no alternatives or substitutes for PFHxS in many applications. Therefore, PFHxS has been proposed for inclusion in the Authorization List with sunset dates that allow for a transition period for industry and downstream users to find safer alternatives and control the risks of PFHxS.

2. Medium-chained chlorinated paraffins (MCCP)

Medium-chained chlorinated paraffins

MCCP are a group of chlorinated hydrocarbons consisting of carbon chains with 14 to 17 carbon atoms, applied primarily as flame retardants and plasticisers in rubber, paints, adhesives, and textiles. MCCP are persistent, bioaccumulative, toxic to aquatic organisms, and may cause adverse effects on the liver, kidney, and thyroid gland in humans and wildlife. MCCP are widespread contaminants in the environment, including air, freshwater, sediments, and biota, as well as in food and human breast milk.

ECHA’s Member State Committee (MSC) has proposed MCCP as an SVHC due to their properties that cause probable serious effects to human health and the environment. MSC has also identified MCCP as a substance of concern under the Water Framework Directive and the Stockholm Convention on Persistent Organic Pollutants. In addition, MSC has considered that MCCP are not adequately controlled under existing legislation and that there are alternatives and substitutes available for many applications of MCCP. Therefore, MCCP has been recommended for inclusion in the Authorization List with transitional arrangements that provide exemptions for certain uses, such as in articles manufactured before the sunset date.

3. Phthalic anhydride (PA)

Phthalic anhydride

PA is an organic compound used primarily as a chemical intermediate in the production of plastics, resins, dyes, and pharmaceuticals. PA is irritating to the skin, eyes, and respiratory system and may cause asthma, allergies, and liver toxicity in exposed workers. PA is also toxic to aquatic life and may persist in the environment. PA has been registered under REACH with tonnage bands up to 1000 tonnes per year.

ECHA’s Committee for Socio-Economic Analysis (SEAC) has proposed PA to be identified as an SVHC due to its hazardous properties that entail significant risks to human health and the environment and because PA is not adequately controlled under REACH or other EU legislation. SEAC has also noted that there are safer alternatives and substitutes for many uses of PA and that the benefits of such uses do not outweigh the identified risks. Therefore, PA has been recommended for inclusion in the Authorization List with transitional arrangements that allow for exemptions for certain applications, such as those related to health and safety.

In conclusion, the inclusion of the top 3 substances in the Authorization List serves to ensure that the risks of these chemicals are adequately controlled and that the use and trade of these substances are accompanied by the necessary measures to protect human health and the environment. It also encourages the substitution of hazardous substances with safer alternatives and promotes a more sustainable and innovative industrial production and consumption.

Implications of Inclusion in the Authorisation List

Implications of Inclusion in the Authorisation List

When a chemical is included in the authorisation list, it means that its use is restricted and requires authorisation from the European Chemicals Agency (ECHA) before it can be placed on the market or used. Such an inclusion on the list has many implications, some of which are discussed below.

1. Increased Control: Chemicals listed on the authorisation list are subject to stricter control measures. Manufacturers and importers are required to provide information about the risks associated with the chemical and ways to control them. This includes information about the chemical’s properties, potential hazards, exposure limits, and safe handling practices. End-users (companies that use the chemical) are also required to follow these instructions.

2. Reduction of Health Hazards: Chemical substances that are considered hazardous to human health or the environment are often included in the authorisation list. Inclusion in the list means that manufacturers and importers must provide information on the safe use and handling of the substance. This helps reduce exposure to hazardous substances and lowers the risk of health hazards and accidents.

3. Promotion of Substitution: Inclusion in the authorisation list encourages the substitution of harmful chemicals with safer alternatives. Manufacturers and importers must provide information on alternatives to the listed substance. End-users are also encouraged to seek out safer alternatives. This promotes the use of safer chemicals that have less negative impact on the environment and human health.

4. Increased Costs: The process of obtaining an authorisation for a listed substance can be lengthy, complex and costly. The manufacturer or importer of a substance must submit a full application for authorisation, which includes a detailed analysis of the risks and hazards associated with the substance. The application process involves consultation with ECHA and other interested parties. The fees associated with an application may include the cost of data gathering, testing, and analysis. The cost of obtaining an authorisation can be significant, particularly for small and medium-sized companies.

Overall, the implications of inclusion in the authorisation list are far-reaching and can have significant consequences for manufacturers, importers, and end-users. The enhanced control, reduction of health hazards, promotion of substitution, and increased costs associated with the authorisation process are all factors that must be considered when a chemical is included on the list.

Conclusion and Future of the Authorisation List

Conclusion and Future of the Authorisation List

The authorisation list is international regulation that seeks to control and limit the negative impacts of hazardous substances on human health and the environment by imposing regulations and restrictions on the use of these substances. The list covers chemicals that are considered to pose risks and are placed under a rigorous testing regime and authorization process before they are allowed on the market. Over the years, the list has been successful in reducing the harm caused by hazardous chemicals while promoting the production and use of safer alternatives.

The authorization process has helped to prioritize risk management measures, ensuring that hazardous substances are only used when there are no alternative solutions. This system has allowed for substances of high concern to be replaced with safer alternatives that have less impact on human health and the environment. As a consequence of this, the authorisation list has contributed to a reduction in the exposure to hazardous substances, minimizing the risk of their negative impacts.

Looking to the future, it is critical to continue identifying hazardous substances and assess their risks to ensure their inclusion in the authorization list. There should be a comprehensive approach to assess all substances and a prioritization of substances based on what is most hazardous. Assessing chemicals should involve an evaluation of the risks to human health and the environment, including the mechanisms that may enhance or minimize risk exposure.

Monitoring the safety of substances should be an ongoing process, involving continued analysis of their impacts and results from research studies. Results from these studies should then be used to update the regulation and improve the risk management framework of chemicals. Regular reviews of the authorisation list can ensure that it remains an effective tool in controlling the use of hazardous substances and promoting safer alternatives.

As technology evolves, there is a growing need for a transition to safer alternatives. The importance of sustainable and safe production methods has been underscored by the ongoing discussion around the circular economy. It is essential to promote the production and use of chemicals that are safer, non-toxic and environmentally friendly. Producers should be encouraged to design safe substances, preventing the release of toxic chemicals into the environment.

The authorisation process should be more public and transparent to give citizens the opportunity to participate in decision-making and express concerns about the use of hazardous substances. Cooperation of various stakeholders such as NGOs, industry, and public authorities is necessary to ensure that effective risk management solutions are implemented.

In conclusion, the authorisation list has made significant strides in improving the safety of hazardous chemicals, promoting the use of safer alternatives, and reducing the exposure to these substances. However, we must continue to make strides towards creating a more sustainable future. To ensure that hazardous substances are managed effectively, the process of authorization and inclusion of a substance on the authorisation list should be a dynamic process that integrates new insights and data as they become available.

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