REACH – Registration, Evaluation, Authorization, and Restriction of Chemicals is a regulation implemented by the European Union (EU) to manage and control the use of chemicals within the EU. REACH came into effect on June 1, 2007, and its primary aim is to ensure a high level of protection for human health and the environment while also promoting the competitiveness of the European chemicals industry.
We explored how to “Meet REACH requirements”. To ensure full compliance, EU manufacturers must understand 3 essential lists:
- The Candidate List, also known as Substances of Very High Concern (SVHC)
- The Authorisation List (Annex XIV)
- The Restriction List (Annex XVII)
1. The Candidate List, also known as Substances of Very High Concern (SVHC)
The SVHC or Candidate Lists comprise chemical substances potentially harmful to human health or the environment. These substances are subjected to further evaluation and may be included in the Authorization List. If a substance is on the Candidate List, manufacturers, importers, and downstream users have certain obligations. They must notify the European Chemicals Agency (ECHA) if their product contains an SVHC with a concentration greater than 0.1% by weight. The purpose of this list is to prioritize and monitor substances for further assessment and regulation.
The SVHC list is updated twice a year. Companies may need to re-evaluate product compliance and obtain data from suppliers to comply with REACH regulations.
2. The Authorisation List (Annex XIV)
The Authorization List, also referred to as Annex XIV of REACH, comprises substances of very high concern (SVHC) that pose significant risks to human health or the environment. If a chemical substance is included in the Authorization List, companies must obtain authorization from ECHA to use that substance unless a specific exemption is applicable. The main objective of the Authorization List is to phase out or restrict the use of hazardous substances over time while promoting safer alternatives.
3. The Restriction List (Annex XVII)
The Restriction List, which is also known as Annex XVII of REACH, comprises specific limitations on manufacturing, marketing, or using certain hazardous chemicals. These limitations are legally binding and aim to reduce risks related to specific chemicals, products, or procedures. The limitations may include concentration thresholds, bans on usage, or other measures to manage the use of specific substances.
To sum up, the lists have distinct roles under the REACH regulation:
- The Candidate List identifies substances of very high concern for further evaluation.
- The Authorization List requires specific authorization for the use of listed substances.
- The Restriction List imposes legal restrictions on the use of certain hazardous substances.
These lists regulate the use of chemicals in the European Union, aiming to protect human health and the environment. Companies that deal with chemicals listed under these regulations must comply with the corresponding requirements and regulations under REACH.
Why choose APA for Compliance Management?
APA has more than 20 years of regulatory experience, which enables us to offer constant assistance to businesses striving to comply with REACH regulations. Our advanced Compliance Management System, called ‘Greencheck‘, helps you to carry out risk assessments efficiently, manage compliance effortlessly, and facilitate accurate and timely reporting. This ultimately improves your overall regulatory operations, making the process easier and more effective.
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